MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® ALL- SILICONE FOLEY CATHETER TRAY; CATHETER, URETHRAL

Model Number	A902414
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Foley catheter kit missing 1 of the 3 sponges used with betadine to clean urethral area.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® ALL- SILICONE FOLEY CATHETER TRAY
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): C. R. BARD, INC.; 1211 mary magnan blvd.; madison GA 30650
• MDR Report Key: 23989359
• Report Number: 23989359
• Device Sequence Number: 10222294
• Product Code: GBM
• UDI-Device Identifier: 00801741074035
• UDI-Public: (01)00801741074035
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/17/2025
• Report Date (Section F): 12/17/2025

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: A902414
• Device Catalogue Number: A902414
• Device Lot Number: NGKV1279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2026
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/17/2025