BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE

    MDR report key: 6124051 · Received November 23, 2016

    Report

    Report Number
    6124051
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    September 22, 2016
    Report Date
    November 2, 2016
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO GAIN ARTERIAL ACCESS ON A PATIENT, TWO MICROPUNCTURE KITS WERE OPENED AND ATTEMPTED TO UTILIZE. BOTH MICROPUNCTURE SHEATHS HAD SHREDDED WHILE EXCHANGING FOR A 5 FRENCH SHEATH. BOTH ARE FORM THE SAME LOT NUMBER: 7120807, 21G, 0.018", 4.0FR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774376 MICROPUNCTURE INTRODUCER, CATHETER DYB COOK, INC. 7120807

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR OTHER, TPA INFUSION