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

Model Number 175816

Device Problems Difficult to Remove (1528); Retraction Problem (1536); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/04/2023

Event Type  malfunction  

Event Description

Upon an attempt to remove a male patient's urinary catheter, there was noted to be a defect in the distal most part of the balloon of the catheter.When the 10ccs of water were removed from the balloon, the silicone appears not to have retracted all the way back into original position, and created a silicone fold.The presence of the fold caused the catheter to become lodged just inside the pt's urinary meatus, preventing nursing staff from being able to remove the last bit of the foley catheter all the way.Primary nurse left catheter in place and notified the intensivist.On call urology notified.Patient pulled it out himself.

• Brand Name: BARDEX LUBRI-SIL 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: 16520995
• MDR Text Key: 311053433
• Report Number: 16520995
• 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: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 175816
• Device Catalogue Number: 175816
• Device Lot Number: NGGN1992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20805 DA
• Patient Sex: Male
• Patient Weight: 70 KG