MAUDE Adverse Event Report: AMSINO MEDICAL (SHANGHAI) CO., LTD MCKESSON BRANDS; CATHETER, FOLEY COUDE TIP LTX 16FR 5CC 16"

Catalog Number	16-LFOL516C
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical code e - 4581 splitting of the penis following use of urethral catheter.
Event or Problem Description
It was reported by the customer that following use of these catheters, short term male patients experienced splitting of the penis.

• Brand Name: MCKESSON BRANDS
• Common Device Name: CATHETER, FOLEY COUDE TIP LTX 16FR 5CC 16"
• Manufacturer (Section D): AMSINO MEDICAL (SHANGHAI) CO., LTD; building no. 1-3, 16; lane 355 huazhe road; songjiang export processing zo, shanghai 20161 3; CH 201613
• MDR Report Key: 22887733
• Report Number: 1451040-2025-00077
• Device Sequence Number: 4915382
• Product Code: GBM
• UDI-Device Identifier: 10612479246925
• UDI-Public: 10612479246925
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2025
• Report Date (Section F): 08/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 16-LFOL516C
• Device Lot Number: CAOE02-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/28/2025
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/25/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/25/2025