MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER; CATHETER, COUDE

Model Number	A902916
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Rn was attempting to care for intubated patient, and when she pulled the patients blanket back, she noticed a large puddle of urine under the patient.There was no obvious hole or visual failure with the foley, and it seemed to just not be connecting properly, leading to the puddle.This rn was not sure how long the foley had been a problem with this specific patient, but this at least the fifth time in the last two weeks our icu has had a problem with this specific type of foley catheter.This failure could lead to potential skin breakdown for an intubated patient, which could lead to infection control issues.All five of the failures were with five different patients.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: CATHETER, COUDE
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 24505543
• Report Number: 24505543
• Device Sequence Number: 9943038
• Product Code: EZC
• UDI-Device Identifier: 00801741074073
• UDI-Public: (01)00801741074073
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2026
• Report Date (Section F): 02/27/2026

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 Model Number: A902916
• Device Catalogue Number: A902916
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR
• Patient Sex: Male
• Date Report Sent to FDA: 02/27/2026