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

Catalog Number	16-LFOL516C
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that they were experiencing issues with balloons not inflating and leaking.On one occasion, it was difficult to remove the foley catheter from the patient.

• Brand Name: MCKESSON BRANDS
• Common Device Name: CATHETER, FOLEY COUDE TIP LTX 16FR 5CC 16"
• Manufacturer (Section D): AMSINO MEDICAL (KUNSHAN) CO., LTD.; 582 lidu road; qiandeng town; kunshan, jiangsu 21534 3; CH 215343
• MDR Report Key: 20267433
• Report Number: 1451040-2024-00045
• Device Sequence Number: 7418858
• Product Code: EZL
• UDI-Device Identifier: 10612479246925
• UDI-Public: 10612479246925
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/20/2024
• Report Date (Section F): 09/20/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 16-LFOL516C
• Device Lot Number: CAOD04-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/26/2024
• Device Age: 4 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2024
• 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: 09/20/2024