MAUDE Adverse Event Report: C. R. BARD, INC. BARD® URINE METER FOLEY CATHETER TRAY WITH BARDEX® LUBRICATH® FOLEY CATHETER; CATHETER, COUDE

Model Number	902916
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Attempted to insert foley catheter for patient with urinary retention, the catheter was discolored at the end connected to the foley bag, while doing balloon check the balloon inflated but would not deflate.Stopped procedure got another kit from the supply closet and encountered the same problem with the discoloration and balloon.Stopped procedure brought 2 kits back this time so i did not have to go far if the same problem persisted, the 3rd kit was not discolored and the balloon work.

• Brand Name: BARD® URINE METER FOLEY CATHETER TRAY WITH BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: CATHETER, COUDE
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 21025898
• Report Number: 21025898
• Device Sequence Number: 8191551
• Product Code: EZC
• UDI-Device Identifier: 00801741024863
• UDI-Public: (01)00801741024863
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/26/2024
• Report Date (Section F): 11/26/2024

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
• Operator of Device: Health Professional
• Device Model Number: 902916
• Device Catalogue Number: 902916
• Device Lot Number: NGHZ2127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Date Report Sent to FDA: 11/26/2024