MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CARBOFLO VASCULAR GRAFT

Model Number 10S05TWC

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided; therefore, a lot history review is currently being performed.The device was not returned to the manufacturer for evaluation.The investigation is therefore inconclusive due to no sample return.Based on the available information, the definitive root cause could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 10s05twc vascular graft allegedly experienced device contamination with chemical or other material.This information was received from one source.There was no patient involved as there was no patient contact.

• Brand Name: CARBOFLO VASCULAR GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9979690
• MDR Text Key: 188666521
• Report Number: 2020394-2020-03078
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741021107
• UDI-Public: (01)00801741021107
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10S05TWC
• Device Catalogue Number: 10S05TWC
• Device Lot Number: VTDV0526
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/20/2020
• Type of Device Usage: N
• Patient Sequence Number: 1