MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® IC COMPLETE CARE®; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Model Number	A304718A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Registered nurse (rn) placed foley in patient at the emergency department.When attempting to inflate balloon with saline-filled syringe, the balloon hub broke apart.The foley was removed and a new foley was placed in the patient.
Event or Problem Description
Registered nurse (rn) placed foley in patient at the emergency department.When attempting to inflate balloon with saline-filled syringe, the balloon hub broke apart.The foley was removed and a new foley was placed in the patient.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® IC COMPLETE CARE®
• Common Device Name: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 20733434
• Report Number: 20733434
• Device Sequence Number: 15546123
• Product Code: MJC
• UDI-Device Identifier: 00801741100376
• UDI-Public: (01)00801741100376(17)250930(10)NGJT3548
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 11/11/2024
• Report Date (Section F): 11/11/2024

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: A304718A
• Device Catalogue Number: A304718A
• Device Lot Number: NGJT3548
• 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: 11/20/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 11/20/2024
• 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: 86 YR
• Patient Sex: Male
• Date Report Sent to FDA: 11/11/2024