BEUDAMED
    FDA Adverse Event Other Summary report: N

    MCKESSON BRANDS

    MDR report key: 22977231 · Received September 5, 2025

    Report

    Report Number
    1451040-2025-00083
    Event Type
    Other
    Date Received
    September 5, 2025
    Date of Event
    August 18, 2025
    Report Date
    September 5, 2025
    Manufacturer
    SHINCHANG MEDICAL CO., LTD
    Product Code
    QOI
    UDI-DI
    10612479212593
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT AFTER ACCESSING THE PATIENT AND FLUSHING THE CATHETER, LEAKAGE OCCURS FROM THE BASE OF 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
    263590 MCKESSON BRANDS CATHETER, IV 24GX3/4" QOI SHINCHANG MEDICAL CO., LTD KSN2409 10612479212593

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown