MAUDE Adverse Event Report: AMSINO MEDICAL (SHANGHAI) CO., LTD. MCKESSON BRANDS; CATHETER, FOLEY STRT TIP SIL COATED LTX 22FR 30CC

Catalog Number	16-SLFOL3022
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Unspecified Kidney or Urinary Problem (4503)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical code e - 4503.Bleeding following removal of urethral catheter.
Event or Problem Description
It was reported by the customer that catheter was difficult to remove.Balloon did deflate to remove.Patient experienced bleeding during removal.

• Brand Name: MCKESSON BRANDS
• Common Device Name: CATHETER, FOLEY STRT TIP SIL COATED LTX 22FR 30CC
• Manufacturer (Section D): AMSINO MEDICAL (SHANGHAI) CO., LTD.; building no. 1-3, 16, lane; 355 huazhe rd,; songjiang export processing zo, shanghai 20161 3; CH 201613
• MDR Report Key: 23863798
• Report Number: 1451040-2025-00122
• Device Sequence Number: 9350253
• Product Code: GBM
• UDI-Device Identifier: 10612479246987
• UDI-Public: 10612479246987
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/22/2025
• Report Date (Section F): 12/22/2025

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?: Yes
• Device Catalogue Number: 16-SLFOL3022
• Device Lot Number: CAOE05-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/01/2025
• Device Age: 7 MO
• Event Location: Home
• Date Report to Manufacturer: 12/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2025
• 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: 12/22/2025