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

Model Number VLT2547C

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for the reported malfunction and a lot history review was performed.A device was not returned for evaluation, but one electronic photo was provided.The investigation was inconclusive for the reported device markings issue.A root cause could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.The information received indicated that model vlt2547c vascular graft allegedly experienced device markings issue.This information was received from one source.The malfunction involve a patient with no reported consequences.Age, weight, and gender were not provided.

• Brand Name: VENAFLO 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: 9587435
• MDR Text Key: 180324750
• Report Number: 2020394-2020-00226
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741020537
• UDI-Public: (01)00801741020537
• 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: 01/14/2020

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: VLT2547C
• Device Catalogue Number: VLT2547C
• Device Lot Number: VTCT0517
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/14/2020
• Type of Device Usage: N
• Patient Sequence Number: 1