BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON BRANDS

    MDR report key: 23990647 · Received January 7, 2026

    Report

    Report Number
    1451040-2026-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    January 5, 2026
    Report Date
    January 7, 2026
    Manufacturer
    SHINCHANG MEDICAL CO., LTD
    Product Code
    QOI
    UDI-DI
    10612479212562
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT ITEM WAS KINKING AND BLOOD NOT FLOWING THROUGH. WHEN THE IV WAS INSERTED AND THE NEEDLE WAS REMOVED, THE CATHETER (TUBE) KINKED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49398 MCKESSON BRANDS CATHETER, IV 22GX1" QOI SHINCHANG MEDICAL CO., LTD KSO2504 10612479212562

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown