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

Device Problems Material Puncture/Hole (1504); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 05/22/2022

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 14564138
• MDR Text Key: 293085458
• Report Number: 14564138
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741024979
• UDI-Public: (01)00801741024979(17)230630(10)NGFW2438
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Date Report Sent to FDA: 05/27/2022
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White