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

Model Number VL5006C

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review is currently being performed.The sample returned to the manufacturer for inspection/evaluation.A photo was provided for a review.The device is labeled for single use.The investigation of the reported event is currently underway.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model vl5006c vascular graft allegedly experienced device contamination with chemical or other material.The information was received from a single source.This malfunction did not involve a patient as there was no patient contact.Patients' age, weight and gender were not provided.

Manufacturer Narrative

H10: as the lot number for the device was provided, a lot history review is currently being performed.The sample returned to the manufacturer for inspection/evaluation.A photo was provided for a review.Therefore, the investigation is inconclusive for alleged contamination of foreign matter issue.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: g4.H11: h6 (results, conclusion).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model vl5006c vascular graft allegedly experienced device contamination with chemical or other material.The information was received from a single source.This malfunction did not involve a patient as there was no patient contact.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
• MDR Report Key: 10722926
• MDR Text Key: 212695586
• Report Number: 2020394-2020-06005
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741020452
• UDI-Public: (01)00801741020452
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: VL5006C
• Device Catalogue Number: VL5006C
• Device Lot Number: VTDY0234
• Date Manufacturer Received: 12/31/2020
• Patient Sequence Number: 1