MAUDE Adverse Event Report: C. R. BARD, INC. BARD URINE METER FOLEY TRAY WITH LUBRI-SIL ALL-SILICONE FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number	942216
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse inflated the foley balloon to test it before inserting into the patient and the balloon did not inflate.There was a hole in the balloon and sterile water squirted out of it.

• Brand Name: BARD URINE METER FOLEY TRAY WITH LUBRI-SIL ALL-SILICONE FOLEY CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 20396111
• Report Number: 20396111
• Device Sequence Number: 15455725
• Product Code: EZL
• UDI-Device Identifier: 00801741024979
• UDI-Public: (01)00801741024979(17)260131(10)NGHY3197
• 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): 10/04/2024
• Report Date (Section F): 10/04/2024

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: 942216
• Device Catalogue Number: 942216
• Device Lot Number: NGHY3197
• 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: 10/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/04/2024