BD SYRINGE 5ML HEPARIN 306424

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2019-08-26 for BD SYRINGE 5ML HEPARIN 306424 manufactured by Bd Medical (bd West) Medical Surgical.

MAUDE Entry Details

• Report Number: 1911916-2019-00856
• MDR Report Key: 8931027
• Report Source: HEALTH PROFESSIONAL,OTHER,USE
• Date Received: 2019-08-26
• Date of Report: 2019-09-03
• Date of Event: 2019-08-06
• Date Mfgr Received: 2019-08-08
• Device Manufacturer Date: 2018-10-03
• Date Added to Maude: 2019-08-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: BDX BRETT WILKO
• Manufacturer Street: 9450 SOUTH STATE STREET
• Manufacturer City: SANDY UT 84070
• Manufacturer Country: US
• Manufacturer Postal: 84070
• Manufacturer Phone: 8015652341
• Manufacturer G1: BD MEDICAL (BD WEST) MEDICAL SURGICAL
• Manufacturer Street: 1852 10TH AVENUE
• Manufacturer City: COLUMBUS NE 68601
• Manufacturer Country: US
• Manufacturer Postal Code: 68601
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BD SYRINGE 5ML HEPARIN
• Generic Name: HEPARIN, VASCULAR ACCESS FLUSH
• Product Code: NZW
• Date Received: 2019-08-26
• Catalog Number: 306424
• Lot Number: 827575N
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BD MEDICAL (BD WEST) MEDICAL SURGICAL
• Manufacturer Address: 1852 10TH AVENUE COLUMBUS NE 68601 US 68601

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-08-26