MAUDE Adverse Event Report: WELL LEAD MEDICAL CO. LTD MCKESSON BRANDS; CATHETER, FOLEY STRT TIP SIL COATED LTX 16FR 5CC

Catalog Number	16-SLFOL516
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	04/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer that the catheter became clogged in the patient.Patient was sent to the er where blood pressure was reported to be over 300 mm hg.

• Brand Name: MCKESSON BRANDS
• Common Device Name: CATHETER, FOLEY STRT TIP SIL COATED LTX 16FR 5CC
• Manufacturer (Section D): WELL LEAD MEDICAL CO. LTD; c-4 jinhu industrial estate; hualong, pan yu; guangzhou, guangdong 51143 4; CH 511434
• MDR Report Key: 25015228
• Report Number: 1451040-2026-00019
• Device Sequence Number: 9506110
• Product Code: GBM
• UDI-Device Identifier: 10612479245850
• UDI-Public: 10612479245850
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/28/2026
• Report Date (Section F): 04/28/2026

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-SLFOL516
• Device Lot Number: CAOE06-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/13/2026
• Device Age: 10 MO
• Event Location: Home
• Date Report to Manufacturer: 04/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2026
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/28/2026