MAUDE Adverse Event Report: C. R. BARD, INC. BARDEX® URETHRAL CATHETER ROBINSON MODEL; CATHETER, UROLOGICAL

Model Number	056108
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Staff opened a catheter package and noticed that the catheter material appeared faded and cracked.They did not use the catheter and chose another product that passed a visual inspection.

• Brand Name: BARDEX® URETHRAL CATHETER ROBINSON MODEL
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 24799643
• Report Number: 24799643
• Device Sequence Number: 13428509
• Product Code: KOD
• UDI-Device Identifier: 00801741033490
• UDI-Public: (01)00801741033490(17)270731(10)NGHS1096
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/26/2026
• Report Date (Section F): 03/26/2026

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: 056108
• Device Catalogue Number: 056108
• Device Lot Number: NGHS1096
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/26/2026