MAUDE Adverse Event Report: SHINCHANG MEDICAL CO., LTD MCKESSON BRANDS; CATHETER, IV 24GX3/4"

Catalog Number	6049
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that catheters leak from the hub.No information was received regarding any serious injury as a result of the product issue.

• Brand Name: MCKESSON BRANDS
• Common Device Name: CATHETER, IV 24GX3/4"
• Manufacturer (Section D): SHINCHANG MEDICAL CO., LTD; #320 gongdan-dong gumi-shi; gyeongsangbuk-do, 730-0 30,; KS 730-030,
• MDR Report Key: 23322805
• Report Number: 1451040-2025-00097
• Device Sequence Number: 21476038
• Product Code: QOI
• UDI-Device Identifier: 10612479212593
• UDI-Public: 10612479212593
• 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): 10/17/2025
• Report Date (Section F): 10/17/2025

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: 6049
• Device Lot Number: KSN2413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/09/2025
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2025
• 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: 10/17/2025