MAUDE Adverse Event Report: BARD BARDEX; BARDEX ALL SILICONE FOLEY CATHETER

Model Number BARDEX ALL SILICONE FOLEY CATHETER

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2017

Event Type  malfunction  

Event Description

An 8 french silicone foley catheter with hole noticed at y-site.Found during a voiding cystourethrogram.

• Brand Name: BARDEX
• Type of Device: BARDEX ALL SILICONE FOLEY CATHETER
• Manufacturer (Section D): BARD; covington GA 30014
• MDR Report Key: 7108439
• MDR Text Key: 94746108
• Report Number: MW5073907
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/08/2017

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: Health Professional
• Device Model Number: BARDEX ALL SILICONE FOLEY CATHETER
• Device Lot Number: NGBW0446
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Weight: 34