MAUDE Adverse Event Report: C.R. BARD, INC. BARDEX® LUBRICATH® FOLEY CATHETER; CATHETER, FOLEY

Model Number 902816

Device Problem Hole In Material (1293)

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

Event Date 09/06/2017

Event Type  malfunction  

Event Description

There was a hole noticed in the bag at the seal that attaches to the drainage tubing.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Type of Device: CATHETER, FOLEY
• Manufacturer (Section D): C.R. BARD, INC.; 1211 mary magnan blvd.; madison GA 30650
• MDR Report Key: 6910620
• MDR Text Key: 88027563
• Report Number: 6910620
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 902816
• Device Catalogue Number: 902816
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR