BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMMI MICRO-DRAW

    MDR report key: 8929901 · Received August 26, 2019

    Report

    Report Number
    8929901
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    July 3, 2019
    Report Date
    August 12, 2019
    Manufacturer
    HUMMINGBIRD MED
    Product Code
    KST
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN UAC WAS ACCESSED WITH HUMMI MICRO DRAW, AIR BUBBLES WERE NOTED WITH DRAWBACK. THERE WERE DROPS OF BLOOD LEAKING FROM THE HUB OF THE CATHETER. THE TRANSFER DEVICE WAS REMOVED AND PATIENT HAD A REDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725680 HUMMI MICRO-DRAW SYSTEM, BLOOD COLLECTION KST HUMMINGBIRD MED

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA