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

Model Number	IV CATHETER 24G*3/4"
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported leakage of medication from the iv catheter during flushing at the injection site.The event date was reported as (b)(6) 2026.No patient injury or death was reported.Samples were discarded by the customer and the lot number was unavailable.The manufacturer conducted an investigation based on the most recently produced lot and no abnormalities were identified in the dhr review.The manufacturer determined that improper assembly between the wedge and tube may cause leakage defects.Previously, the vision inspection system inspected only one side of the assembly using a single camera, which could result in undetected defects in blind spots.Corrective action was implemented by installing an additional camera on the opposite side to enable full 360-degree inspection.
Additional Manufacturer Narrative
The complaint reported leakage at the injection site during flushing of an iv catheter.No patient injury was reported.The device sample and lot number were not available for evaluation.Investigation is limited due to lack of returned sample.Complaint has been documented and will be monitored through the manufacturer's quality system.

• Brand Name: MCKESSON BRANDS
• Common Device Name: CATHETER, IV 24GX3/4"
• Manufacturer (Section D): SHINCHANG MEDICAL CO.,LTD.; 144, 1gongdan-ro 6-gil; gumi-si, gyeongbuk 39385 ; KS 39385
• Manufacturer (Section G): SHINCHANG MEDICAL CO., LTD.; 144, 1gongdan-ro 6-gil; gumi-si, gyeongbuk 39385 ; KS 39385
• Manufacturer Contact: minsu chu ; 144, 1gongdan-ro 6-gil; gumi-si, gyeongbuk 39385 ; KS 39385
• MDR Report Key: 25134125
• Report Number: 3003169040-2026-00001
• Device Sequence Number: 18470378
• Product Code: FOZ
• UDI-Device Identifier: 10612479212593
• UDI-Public: 10612479212593
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K071382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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
• Operator of Device: Health Professional
• Device Model Number: IV CATHETER 24G*3/4"
• Device Catalogue Number: 6049
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown