MAUDE Adverse Event Report: MCKESSON MEDICAL-SURGICAL INC. MCKESSON; CATHETER, RETENTION TYPE, BALLOON

Model Number	16-SLFOL516
Health Effect - Clinical Code	Contamination, chemical (2455)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
16f foley catheter balloon malfunctioned.Balloon did not drain when it was time to discontinue the foley after bladder instillation.Urine drained appropriately throughout patients treatment.10cc was used to fill balloon.Attempted to use multiple empty syringes to deflate balloon on the catheter valve.Balloon did not deflate on its own.Could not manually aspirate the balloon.The y tip was cut in order for the balloon to deflate thus possibly exposing patient / nurses / environment to chemo.

• Brand Name: MCKESSON
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC.; 1338 interstate centre blvd su; ellabell GA 31308
• MDR Report Key: 22165947
• Report Number: 22165947
• Device Sequence Number: 7788868
• Product Code: EZL
• UDI-Device Identifier: 10612479245850
• UDI-Public: (01)10612479245850
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/30/2025
• Report Date (Section F): 05/30/2025

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: 16-SLFOL516
• Device Lot Number: (10)CAOE01-03
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/09/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2025
• 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 Age: 72 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/30/2025