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

Model Number F8008C

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 lot history review will be performed.The sample was not returned to the manufacturer for inspection/evaluation; however, the photo was provided for review.The company is still investigating the issue at this time.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model f8008c vascular graft allegedly experienced material split, cut or torn.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, weight and gender of the patient were not provided.

Manufacturer Narrative

H10: as the lot number for the device was provided, a lot history review will be performed.The sample was not returned to the manufacturer for inspection/evaluation; however, the photo was provided for review.Therefore, the investigation is inconclusive for the reported torn graft.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.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 indicated that model f8008c vascular graft allegedly experienced material split, cut or torn.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, weight and gender of the patient were not provided.

• Brand Name: CARBOFLO VASCULAR GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10752439
• MDR Text Key: 213650288
• Report Number: 2020394-2020-06226
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741021466
• UDI-Public: (01)00801741021466
• 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: 01/07/2021

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
• Device Operator: No Information
• Device Model Number: F8008C
• Device Catalogue Number: F8008C
• Device Lot Number: VTDS0542
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 12/31/2020
• Supplement Dates FDA Received: 01/07/2021
• Patient Sequence Number: 1