BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON BRANDS

    MDR report key: 22715048 · Received August 5, 2025

    Report

    Report Number
    1451040-2025-00061
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 23, 2025
    Report Date
    August 5, 2025
    Manufacturer
    SHINCHANG MEDICAL CO., LTD
    Product Code
    QOI
    UDI-DI
    10612479212593
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2716280 MCKESSON BRANDS CATHETER, IV 24GX3/4" QOI SHINCHANG MEDICAL CO., LTD KSN2413 10612479212593

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown