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

Model Number 40S05C

Device Problem Patient Device Interaction Problem (4001)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for the reported malfunction; therefore, a lot history review is currently being 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 device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 40s05c eptee vascular graft allegedly patient device interaction problem.This information was received from one source.The alleged malfunction had patient involvement but there were no reported patient consequences.The age, weight and gender of the patient was not provided.

Manufacturer Narrative

H10: the lot number was provided for the reported malfunction; therefore, a lot history review is currently being 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 device is labeled for single use.H10: g3.H11: b5, d4.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 cf40a74c eptee vascular graft allegedly patient device interaction problem.This information was received from one source.The alleged malfunction had patient involvement but there were no reported patient consequences.The age, weight and gender of the patient was not provided.

• Brand Name: CARBOFLO VASCULAR GRAFT
• Type of Device: EPTEE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10752358
• MDR Text Key: 213652391
• Report Number: 2020394-2020-06217
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741020780
• UDI-Public: (01)00801741020780
• 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: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 40S05C
• Device Catalogue Number: CF40A74C
• Device Lot Number: VTAZ0214
• Date Manufacturer Received: 09/30/2021
• Patient Sequence Number: 1