BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON BRANDS

    MDR report key: 23170875 · Received September 29, 2025

    Report

    Report Number
    1451040-2025-00089
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    September 11, 2025
    Report Date
    September 29, 2025
    Manufacturer
    SHINCHANG MEDICAL CO., LTD
    Product Code
    QOI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN YOU CONNECT IV INFUSION CORD, WATER AND BLOOD COMES OUT FROM A TINY HOLE. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THE PRODUCT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796950 MCKESSON BRANDS CATHETER, IV 22GX1" QOI SHINCHANG MEDICAL CO., LTD KSO2501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown