MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD PTFE FELT

Model Number 007976

Device Problems Material Erosion (1214); Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided, therefore a lot history review will be performed.The device was not returned for evaluation, therefore the investigation is inconclusive as no objective evidence was provided for review.The definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model 007976 ptfe felt allegedly experienced material erosion and frayed material.The information was received from one source.The malfunction involved a patient with no reported patient injury.The patient's age, weight, and gender were not provided.

• Brand Name: BARD PTFE FELT
• Type of Device: PTFE FELT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791 ; RQ 00791
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9965645
• MDR Text Key: 189145200
• Report Number: 2020394-2020-02820
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 00801741041402
• UDI-Public: (01)00801741041402
• 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: 04/15/2020

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: 007976
• Device Catalogue Number: 007976
• Device Lot Number: HUDU2395
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/15/2020
• Type of Device Usage: N
• Patient Sequence Number: 1