MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®; CATHETER, RETENTION TYPE, BALLOON

Model Number	A303416A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The foley catheter was replaced via rn at 1100.Upon turning patient, at approximately 1150 am, the catheter tube was pulling out of patient and the balloon was deflated.Two nurses examined the catheter balloon further and found a hole in the device balloon.Patient was assessed and it was unknown if any injury was caused to the patient, if so, was minor.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 22506301
• Report Number: 22506301
• Device Sequence Number: 8745939
• Product Code: EZL
• UDI-Device Identifier: 00801741073823
• UDI-Public: 00801741073823
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2025
• Report Date (Section F): 06/25/2025

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
• Operator of Device: Health Professional
• Device Model Number: A303416A
• Device Catalogue Number: A303416A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 38 KG
• Date Report Sent to FDA: 06/25/2025