MAUDE Adverse Event Report: HANGZHOU BEVER MEDICAL DEVICES CO. LTD MCKESSON BRANDS; CATHETER, URETHRAL COUDE UNCOATED PVC MALE 16"14FR

Catalog Number	16-M1614C
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, URETHRAL COUDE UNCOATED PVC MALE 16"14FR
• Manufacturer (Section D): HANGZHOU BEVER MEDICAL DEVICES CO. LTD; building 2, no.1-1, houmuqiao,; cangqian street, yuhang distri; hangzhou, zhejiang 31112 1; CH 311121
• MDR Report Key: 22772758
• Report Number: 1451040-2025-00068
• Device Sequence Number: 18477015
• Product Code: GBM
• UDI-Device Identifier: 10612479213804
• UDI-Public: 10612479213804
• 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): 08/11/2025
• Report Date (Section F): 08/11/2025

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-M1614C
• Device Lot Number: CBVD04-01
• 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: 16 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2025
• 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: 08/11/2025