MAUDE Adverse Event Report: BD MEDICAL HEPARIN POSIFUSH LOCK-FLUSH SYRINGES 10 UNITS/ML 5 ML MG/MG - MILLIGRAMS/MILLIGR; HEPARIN, VASCULAR FLUSH

Lot Number 725291N

Device Problem Nonstandard Device (1420)

Patient Problem Unspecified Infection (1930)

Event Date 05/17/2018

Event Type  Injury  

Event Description

Pt was dispensed affected lots of the recalled bd heparin lock flush syringes.Pt spouse contacted dispensing pharmacy, (b)(6) and believes her husband had an infection as a result of using the heparins lock flushes.Frequency: as needed, route: intravenous.Therapy start date: (b)(6) 2018, therapy end date: (b)(6) 2018.

• Brand Name: HEPARIN POSIFUSH LOCK-FLUSH SYRINGES 10 UNITS/ML 5 ML MG/MG - MILLIGRAMS/MILLIGR
• Type of Device: HEPARIN, VASCULAR FLUSH
• Manufacturer (Section D): BD MEDICAL
• MDR Report Key: 7596061
• MDR Text Key: 111038685
• Report Number: MW5077799
• Device Sequence Number: 2
• Product Code: NZW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/11/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/08/2018
• Device Lot Number: 725291N
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Weight: 90