BARD IMPRA VENAFLO W/CARBON STRAIGHT REF# V5006C *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-01-14 for BARD IMPRA VENAFLO W/CARBON STRAIGHT REF# V5006C * manufactured by *.

Event Text Entries

[17807606] During a revision of left arterial venous shunt, a hole in graft was noted. Shunt removed and replaced with a different product.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 258510
• MDR Report Key: 258510
• Date Received: 2000-01-14
• Date of Report: 2000-01-14
• Date of Event: 1999-12-22
• Date Facility Aware: 1999-12-24
• Report Date: 2000-01-14
• Date Reported to FDA: 2000-01-14
• Date Added to Maude: 2000-01-18
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BARD IMPRA VENAFLO W/CARBON STRAIGHT
• Generic Name: VASCULAR GRAFT
• Product Code: FIQ
• Date Received: 2000-01-14
• Model Number: REF# V5006C
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 250346
• Manufacturer: *
• Manufacturer Address: 1625 W 3RD ST P.O. BOX 1740 TEMPE AZ 852801740 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2000-01-14