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	Insufficient Information (4580)
Date of Event	05/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This report is for the second foley catheter that was placed and failed.A patient come back into the emergency dept saying his foley that had been placed just fell out.It was a 16 fr urometer style foley and it had a pin hole in the balloon on inspection.Then we placed a new 16 fr foley and sent him home.He came back an hour later saying it fell out again, this one had a big vertical tear in the balloon and would not inflate at all.I saved the packaging because it was still in the trash.Then we placed an 18 fr foley and sent him home again.I saved the packaging too just in case it happens again.

• 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: 14564138
• Report Number: 14564138
• Device Sequence Number: 5723118
• Product Code: EZL
• UDI-Device Identifier: 00801741024979
• UDI-Public: (01)00801741024979(17)230630(10)NGFW2438
• 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): 05/27/2022
• Report Date (Section F): 05/27/2022

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: NGFW2438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2022
• 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: Male
• Patient Weight: 73 KG
• Patient Race: White
• Date Report Sent to FDA: 05/27/2022