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

Model Number	VL4006C
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8533234
• Report Number: 2020394-2019-00501
• Device Sequence Number: 13886166
• Product Code: DSY
• UDI-Device Identifier: 00801741020438
• UDI-Public: (01)00801741020438
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: VL4006C
• Device Catalogue Number: VL4006C
• Device Lot Number: VTCW0286
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1