MAUDE Adverse Event Report: AMSINO MEDICAL (SHANGHAI) CO., LTD MCKESSON BRANDS; CATHETER, FOLEY STRT TIP SIL COATED LTX 12FR 5CC

Catalog Number	16-SLFOL512
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the balloon did not deflate and did not drain.Patient (15 years old) was sent to the er where the catheter was able to be removed.No information was received regarding any serious injury as a result of this product issue.

• Brand Name: MCKESSON BRANDS
• Common Device Name: CATHETER, FOLEY STRT TIP SIL COATED LTX 12FR 5CC
• 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: 24497507
• Report Number: 1451040-2026-00014
• Device Sequence Number: 5092128
• Product Code: GBM
• UDI-Device Identifier: 10612479245799
• UDI-Public: 10612479245799
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/03/2026
• Report Date (Section F): 03/03/2026

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 Catalogue Number: 16-SLFOL512
• 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: 02/25/2026
• Device Age: 9 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/03/2026