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	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While filling the balloon of a 14-french foley catheter in the or1 of [redacted] hospital, the foley catheter lumen tubing had a leak.This was caught while filling the balloon.The 10cc syringe normal saline fluid burst upward at the double lumen site.The patient was not injured.No normal saline fluid leaked inside the patient.The foley catheter tip/balloon was intact once promptly removed.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® ALL- SILICONE FOLEY CATHETER TRAY
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): C.R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 23485634
• Report Number: 23485634
• Device Sequence Number: 10559127
• 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): 10/14/2025
• Report Date (Section F): 10/14/2025

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
• 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: 11/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2025
• 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 Sex: Female
• Date Report Sent to FDA: 10/14/2025