MAUDE Adverse Event Report: C. R. BARD, INC. BARDEX® ALL-SILICONE FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number 165816

Device Problems Material Protrusion/Extrusion (2979); Scratched Material (3020)

Patient Problem Pain (1994)

Event Date 11/16/2019

Event Type  malfunction  

Event Description

Bardex 16 french silicone urinary catheter was being removed from a female patient.The balloon was deflated, but the catheter, instead of becoming straight and smooth, had a protruding ridge around the area where the balloon was deflated causing pain to the patient during removal.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 9382567
• MDR Text Key: 168219816
• Report Number: 9382567
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other