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

Model Number	VL5006C
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10722926
• Report Number: 2020394-2020-06005
• Device Sequence Number: 1138956
• Product Code: DSY
• UDI-Device Identifier: 00801741020452
• UDI-Public: (01)00801741020452
• 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): 01/11/2021

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: VL5006C
• Device Catalogue Number: VL5006C
• Device Lot Number: VTDY0234
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 01/11/2021
• Patient Sequence Number: 1