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

Model Number	F8008C
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 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10752439
• Report Number: 2020394-2020-06226
• Device Sequence Number: 16425438
• Product Code: DSY
• UDI-Device Identifier: 00801741021466
• UDI-Public: (01)00801741021466
• 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): 01/07/2021

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