VETERANS HEALTH ADMINISTRATION [VHA] PHARMACY …

VETERANS HEALTH ADMINISTRATION [VHA] PHARMACY BENEFITS MANAGEMENT SERVICES [PBM]

CENTER FOR MEDICATION SAFETY [VA MedSAFE]

Alerts are based on the clinical evidence available at the time of publication. Recommendations are intended to assist practitioners in providing consistent, safe, high quality, and cost effective drug therapy. They are not intended to interfere with clinical judgment. When using dated material, the clinician should consider new clinical information, as available and applicable.

PBM-2018-02

MAY 3, 2018

ITEM:

SPECIFIC

INCIDENT(S):

GENERAL

INFORMATION:

BD PosiFlush Heparin Lock Flush Syringes and BD Pre-Filled Normal Saline Syringes: Recall due to potential for contamination with bacterium.

BD is voluntarily recalling the below items due to a potential for contamination with Serratia marcescens bacterium.

BD was notified by the Food and Drug Administration (FDA) and Centers for Disease

Control and Prevention (CDC) about a potential epidemiological link between catheter

related blood stream infections and the S. marcescens bacterium.

The FDA and CDC identified a small number of cases reported across multiple states.

Affected patients had received treatment using certain BD flush products.

Currently, BD flush products have not tested positive for this bacterium; investigations

are ongoing by BD, FDA, and CDC.

Affected products are listed below (specific lots can be found in the attached excel file or

appendix):

Description

NDC

UPC

Econo #

SYR 100U/ML 2ML FIL 3ML BD 120

08290306528

38290306528

1731835

SYR HEP 3ML FILL 100UN BD 120

08290306514 38290306514

1731041

SYR HEP 3ML FILL 10UN BD 120

08290306521 38290306521

1731512

SYR HEP 5ML FILL 6ML BD 120

08290306515 38290306515

1731256

SYR HEP 5ML FILL 10ML BD 120

08290306531 38290306531

1732130

SYR HEP 100U 5ML FIL 10ML 120

08290306513 38290306513

1731033

SYR HEP 10ML FILL 10UN BD 120

08290036006 38290306509

1402163

SYR HEP 10ML FILL 10UN BD 120

08290306525 38290306525

1731777

SYR HEP 10U 5ML FILL 10ML 120

08290306510 38290306510

1730589

SYR HEP 3ML FILL 3ML BD 120

08290306512 38290306512

1730845

SYR HEP 3ML FILL 5ML BD 120

08290306516 38290306516

1731314

SYR HEP 5ML FILL 10UN BD 120

08290306511 38290306511

1730787

SYR HEP LK 3ML FILL 3ML BD 120

08290306517 38290306517

1731371

SYR SAL 10ML FILL 10ML BD 120

08290306500 38290306500

1732346

SYR SAL 3ML FILL 10ML BD 120

08290306503 38290306503

1461011

SYR SAL 5ML FILL 10ML BD CT30

08290306502 38290306502

1612613

SYR SAL 5ML FILL 5ML BD 120

08290306504 38290306504

1730340

SYR SAL PF 2ML FILL 3ML BD 120

08290306508 38290306508

1730522

SYR SAL PF 3ML FILL 3ML BD 120

08290306507 38290306507

1730415

SYR SAL PF 3ML FILL 5ML BD 120

08290306505 38290306505

1730357

SYR SAL PF BP 10MLFIL10MLBD120 08290306518 38290306518

1731413

PBM 2018-02 | Page 1 of 22

PBM 2018-02 | Page 2 of 22

VETERANS HEALTH ADMINISTRATION [VHA] PHARMACY BENEFITS MANAGEMENT SERVICES [PBM]

CENTER FOR MEDICATION SAFETY [VA MedSAFE]

Serratia marcescens is an opportunistic pathogen with a propensity for healthcare-

associated infection and antimicrobial resistance.

Affected product started shipping from McKesson on April 28, 2017. This alert is an extension of the product sequestration actions in Product Recall Office

Log #13003 (available at: ). Providers should continue to report any adverse reactions with the use of heparin or

saline syringes by entering the information into CPRS' Allergies/Adverse Reactions field and/or via local reporting mechanisms. Adverse events should also be reported, as appropriate, to the VA ADERS program and FDA MedWatch (1-800-FDA-1088, fax 1-800FDA-0178, online at , by mail, or via the VA ADERS program at ).

ACTIONS:

PROVIDER NOTIFICATION: Facility Director (or physician designee): Forward this document to the Facility Chief of Staff (COS).VETERANS HEALTH ADMINISTRATION [VHA] Facility COS (and Chief Nurse Executives): Forward this document to all appropriate providers who prescribe this agent (e.g., HBPC providers, infusion clinic staff, oncology, hematology, neurology, and pharmacy staff, including contract providers, etc.). In addition, forward to the Associate Chief of Staff (ACOS) for Research and Development (R&D). Forward to other VA employees as deemed appropriate. ACOS for R&D: Forward this document to Principal Investigators (PIs) who have authority to practice at the facility and to your respective Institutional Review Board (IRB).

PATIENT NOTIFICATION: Chief of Pharmacy: Within 10 business days of issue (due 05/17/2018): o Determine whether the affected product(s) was administered to any patient(s) for home use. CMOP data will be provided by CMOP representatives to Pharmacy Chiefs. o If an affected lot(s) was administered to patient(s) during home administration, then: Identify the patient(s). Contact the patient(s) who may have received the affected product(s) for home use by letter (or other means). A sample letter can be found at: ments% 20and%20Resources/ASA%20Recall%20Patient%20Letter%20Tem plate. doc . This template can be altered according to site-specific needs. Provide patient(s) who have received the recalled product with instruction on the following: How to return the product being recalled to the pharmacy. How to obtain a new supply of product. Patients should not continue to use the product until they obtain replacement product. When the correct product is received, patients should begin using the new product and return the recalled supply as instructed. o Communicate to PBM/VAMedSAFE that all patient notification actions have been completed via the VHA Alerts and Recalls Website: .

PBM 2018-02 | Page 2 of 22

PBM 2018-02 | Page 3 of 22

VETERANS HEALTH ADMINISTRATION [VHA] PHARMACY BENEFITS MANAGEMENT SERVICES [PBM]

CENTER FOR MEDICATION SAFETY [VA MedSAFE]

SOURCE: REFERENCE(S):

Manufacturer/Distributor

McKesson U.S. Urgent Voluntary Drug Recall [Data on file, Date 04/24/2018]. Manufacturer Recall, written communication, Shayan Akberali, McKesson. April 24, 2018.

ATTACHMENT(S):

BD U.S. Urgent Voluntary Medical Device Recall [Data on file, Date 04/20/2018]. Manufacturer Recall, written communication, VP Global Medical Affairs, BD Medication Delivery Solutions Klaus Hoerauf, BD. April 20, 2018.

See accompanying excel spreadsheet

CONTACTS:

Pharmacy Benefits Management Services (PBM) at (708)786-7862.

PBM 2018-02 | Page 3 of 22

APPENDIX ? AFFECTED PRODUCT

PBM 2018-02 | Page 4 of 22

Description SYR 100U/ML 2ML FIL 3ML BD 120 SYR 100U/ML 2ML FIL 3ML BD 120 SYR 100U/ML 2ML FIL 3ML BD 120 SYR 100U/ML 2ML FIL 3ML BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 100UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 3ML FILL 10UN BD 120 SYR HEP 5ML FILL 6ML BD 120 SYR HEP 5ML FILL 6ML BD 120 SYR HEP 5ML FILL 6ML BD 120

Lot # 713671N 715171N 719121N 710372N 725471N 734211N 733511N 731911N 731211N 727211N 724281N 721611N 709772N 728411N 708782N 721511N 711671N 713691N 715371N 716191N 718121N 719171N 722722N 711171N 730711N 727711N 727611N 726971N 726871N 726571N 726472N 726391N 731921N 711571N 719291N 718091N 717891N 717071N 716771N 714692N 721481N 712271N 710071N 728311N 730511N 730611N

VETERANS HEALTH ADMINISTRATION [VHA] PHARMACY BENEFITS MANAGEMENT SERVICES [PBM]

CENTER FOR MEDICATION SAFETY [VA MedSAFE]

Exp Date 05/15/2019 05/30/2019 07/09/2019 04/12/2019 09/10/2019 12/07/2019 11/30/2019 11/14/2019 11/07/2019 09/28/2019 08/29/2019 08/03/2019 04/06/2019 10/10/2019 03/27/2019 08/02/2019 04/25/2019 05/15/2019 06/01/2019 06/09/2019 06/29/2019 07/09/2019 02/14/2019 10/20/2018 05/02/2019 04/03/2019 04/02/2019 03/25/2019 03/24/2019 03/21/2019 03/20/2019 03/19/2019 05/14/2019 10/24/2018 01/10/2019 12/28/2018 12/26/2018 12/18/2018 12/15/2018 11/25/2018 02/01/2019 11/01/2018 10/09/2018 10/09/2019 10/31/2019 11/01/2019

NDC 08290306528 08290306528 08290306528 08290306528 08290306514 08290306514 08290306514 08290306514 08290306514 08290306514 08290306514 08290306514 08290306514 08290306514 08290306514 08290306514 08290306514 08290306514 08290306514 08290306514 08290306514 08290306514 08290306521 08290306521 08290306521 08290306521 08290306521 08290306521 08290306521 08290306521 08290306521 08290306521 08290306521 08290306521 08290306521 08290306521 08290306521 08290306521 08290306521 08290306521 08290306521 08290306521 08290306521 08290306515 08290306515 08290306515

UPC 38290306528 38290306528 38290306528 38290306528 38290306514 38290306514 38290306514 38290306514 38290306514 38290306514 38290306514 38290306514 38290306514 38290306514 38290306514 38290306514 38290306514 38290306514 38290306514 38290306514 38290306514 38290306514 38290306521 38290306521 38290306521 38290306521 38290306521 38290306521 38290306521 38290306521 38290306521 38290306521 38290306521 38290306521 38290306521 38290306521 38290306521 38290306521 38290306521 38290306521 38290306521 38290306521 38290306521 38290306515 38290306515 38290306515

Econo # 1731835 1731835 1731835 1731835 1731041 1731041 1731041 1731041 1731041 1731041 1731041 1731041 1731041 1731041 1731041 1731041 1731041 1731041 1731041 1731041 1731041 1731041 1731512 1731512 1731512 1731512 1731512 1731512 1731512 1731512 1731512 1731512 1731512 1731512 1731512 1731512 1731512 1731512 1731512 1731512 1731512 1731512 1731512 1731256 1731256 1731256

PBM 2018-02 | Page 4 of 22

APPENDIX ? AFFECTED PRODUCT

PBM 2018-02 | Page 5 of 22

VETERANS HEALTH ADMINISTRATION [VHA] PHARMACY BENEFITS MANAGEMENT SERVICES [PBM]

CENTER FOR MEDICATION SAFETY [VA MedSAFE]

SYR HEP 5ML FILL 6ML BD 120 SYR HEP 5ML FILL 6ML BD 120 SYR HEP 5ML FILL 6ML BD 120 SYR HEP 5ML FILL 6ML BD 120 SYR HEP 5ML FILL 6ML BD 120 SYR HEP 5ML FILL 6ML BD 120 SYR HEP 5ML FILL 6ML BD 120 SYR HEP 5ML FILL 6ML BD 120 SYR HEP 5ML FILL 6ML BD 120 SYR HEP 5ML FILL 6ML BD 120 SYR HEP 5ML FILL 10ML BD 120 SYR HEP 5ML FILL 10ML BD 120 SYR HEP 5ML FILL 10ML BD 120 SYR HEP 5ML FILL 10ML BD 120 SYR HEP 5ML FILL 10ML BD 120 SYR HEP 5ML FILL 10ML BD 120 SYR HEP 5ML FILL 10ML BD 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120 SYR HEP 100U 5ML FIL 10ML 120

735311N 728221N 720821N 726271N 726372N 716582N 716571N 709771N 709671N 707971N 721421N 733421N 729922N 724271N 717491N 716091N 727511N 726511N 726311N 726351N 726221N 726411N 726211N 726451N 726551N 726811N 726821N 726911N 726111N 727021N 725271N 727111N 727512N 727011N 725171N 727821N 734911N 724291N 724472N 724481N 724871N 725511N 725071N 725811N 725181N 725472N 725521N

12/18/2019 10/08/2019 07/26/2019 09/18/2019 09/19/2019 06/13/2019 06/15/2019 04/06/2019 04/05/2019 03/19/2019 08/01/2019 11/29/2019 10/25/2019 08/29/2019 06/22/2019 06/08/2019 10/01/2019 09/21/2019 09/19/2019 09/19/2019 09/18/2019 09/20/2019 09/18/2019 09/20/2019 09/21/2019 09/24/2019 09/24/2019 09/25/2019 09/17/2019 09/26/2019 09/08/2019 09/27/2019 10/01/2019 09/26/2019 09/07/2019 10/04/2019 12/14/2019 08/29/2019 08/31/2019 08/31/2019 09/04/2019 09/11/2019 09/06/2019 09/14/2019 09/07/2019 09/10/2019 09/11/2019

08290306515 08290306515 08290306515 08290306515 08290306515 08290306515 08290306515 08290306515 08290306515 08290306515 08290306531 08290306531 08290306531 08290306531 08290306531 08290306531 08290306531 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513 08290306513

38290306515 38290306515 38290306515 38290306515 38290306515 38290306515 38290306515 38290306515 38290306515 38290306515 38290306531 38290306531 38290306531 38290306531 38290306531 38290306531 38290306531 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513 38290306513

1731256 1731256 1731256 1731256 1731256 1731256 1731256 1731256 1731256 1731256 1732130 1732130 1732130 1732130 1732130 1732130 1732130 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033 1731033

PBM 2018-02 | Page 5 of 22

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