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

Model Number	A942214
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Foley catheter would not empty into canister.On inspection, it was found that the inside of the bag was adhered to the tube where the urine was supposed to empty, when registered nurse (rn) tried to pull bag away from the tube to allow urine to drain, the bag tore.No harm to the patient or the nurse was reported.The foley was discontinued without any further issues.The defective foley was discarded by staff.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER TRAY
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 21240033
• Report Number: 21240033
• Device Sequence Number: 3663989
• Product Code: EZL
• UDI-Device Identifier: 00801741074103
• UDI-Public: (01)00801741074103(17)260831(10)NGJQ2038
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 01/10/2025
• Report Date (Section F): 01/10/2025

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: A942214
• Device Catalogue Number: A942214
• Device Lot Number: NGJQ2038
• 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: 01/27/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2025
• 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: 26 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Date Report Sent to FDA: 01/10/2025