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

Model Number DFM8006SC

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 was performed.The sample was returned to the manufacturer for inspection/evaluation.The investigation is confirmed for graft tear.A definitive root cause for the reported event could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model dfm8006sc bypass graft allegedly experienced material split.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The weight of (b)(6) year old male patient was not provided.

• Brand Name: DISTAFLO BYPASS GRAFT
• Type of Device: BYPASS GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10750348
• MDR Text Key: 213640450
• Report Number: 2020394-2020-06196
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00801741000164
• UDI-Public: (01)00801741000164
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2020

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: DFM8006SC
• Device Catalogue Number: DFM8006SC
• Device Lot Number: VTDX0672
• Date Manufacturer Received: 09/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1