MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP FOLEY TRAY SYSTEM BARDEX LUBRICATH FOLEY CATHETER; CATHETER, COUDE

Model Number	A899916
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
In attempt to remove foley, the balloon would not deflate.Tried multiple times to deflate foley balloon unsuccessfully.Documentation stated 10mls was put into balloon.Only able to draw back 1/2 ml and tubing would collapse.Assessed penis and found balloon in the shaft of the penis in the urethra.Urology said to cut the foley line to get the balloon to deflate slowly with pressure.Balloon would not deflate.Urology consulted bedside.Urology cut distal end of foley completely off and still balloon remained inflated.Urology placed guide wire in balloon port and advanced wire.Removal of guidewire resulted with a gush of water with deflation of balloon.Foley removed without issue with blood present.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM 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: 19748965
• Report Number: 19748965
• Device Sequence Number: 9016147
• Product Code: EZC
• UDI-Device Identifier: 00801741074011
• UDI-Public: (01)00801741074011
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/14/2024
• Report Date (Section F): 06/17/2024

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: A899916
• Device Catalogue Number: A899916
• 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: 07/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2024
• 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: Male
• Date Report Sent to FDA: 06/17/2024