HEPARIN POSIFUSH LOCK-FLUSH SYRINGES 10 UNITS/ML 5 ML MG/MG - MILLIGRAMS/MILLIGR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-12 for HEPARIN POSIFUSH LOCK-FLUSH SYRINGES 10 UNITS/ML 5 ML MG/MG - MILLIGRAMS/MILLIGR manufactured by Bd Medical.

Event Text Entries

[111038685] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5077799
• MDR Report Key: 7596061
• Date Received: 2018-06-12
• Date of Report: 2018-06-11
• Date of Event: 2018-05-17
• Date Added to Maude: 2018-06-13
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PHARMACIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: HEPARIN POSIFUSH LOCK-FLUSH SYRINGES 10 UNITS/ML 5 ML MG/MG - MILLIGRAMS/MILLIGR
• Generic Name: HEPARIN, VASCULAR FLUSH
• Product Code: NZW
• Date Received: 2018-06-12
• Lot Number: 726851N
• Device Expiration Date: 2019-03-24
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BD MEDICAL

Device Sequence Number: 2

• Brand Name: HEPARIN POSIFUSH LOCK-FLUSH SYRINGES 10 UNITS/ML 5 ML MG/MG - MILLIGRAMS/MILLIGR
• Generic Name: HEPARIN, VASCULAR FLUSH
• Product Code: NZW
• Date Received: 2018-06-12
• Lot Number: 725291N
• Device Expiration Date: 2018-03-08
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: BD MEDICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2018-06-12