BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON BRANDS

    MDR report key: 25134125 · Received May 11, 2026

    Report

    Report Number
    3003169040-2026-00001
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    March 17, 2026
    Report Date
    May 11, 2026
    Manufacturer
    SHINCHANG MEDICAL CO.,LTD.
    Product Code
    FOZ
    UDI-DI
    10612479212593
    PMA / PMN Number
    K071382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510623 MCKESSON BRANDS CATHETER, IV 24GX3/4" FOZ SHINCHANG MEDICAL CO.,LTD. IV CATHETER 24G*3/4" UNKNOWN 10612479212593

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown