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

Model Number VL4006C

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

This report summarizes one malfunction event.A review of the event indicated that model vl4006c vascular graft was allegedly torn.This report was received from a single source.Of the one event, did involve patient with no reported patient injury.The patients age, weight and gender were not provided.

Manufacturer Narrative

For the one malfunction, the device was returned for evaluation.Upon visual inspection, it was found that a portion of the cuff had been cut/torn.Therefore, the investigation is confirmed for torn material.Based upon the available information, the definitive root cause is unknown.

Event Description

This report summarizes one malfunction event.A review of the event indicated that model vl4006c vascular graft was allegedly torn.This report was received from a single source.Of the one event, did involve patient with no reported patient injury.The patients 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8533234
• MDR Text Key: 142631326
• Report Number: 2020394-2019-00501
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741020438
• UDI-Public: (01)00801741020438
• 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,Followup
• Report Date: 07/23/2019

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: VL4006C
• Device Catalogue Number: VL4006C
• Device Lot Number: VTCW0286
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2019
• Initial Date FDA Received: 04/19/2019
• Supplement Dates Manufacturer Received: 06/30/2019
• Supplement Dates FDA Received: 07/23/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1