BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST. JOHN KIT

    MDR report key: 4040613 · Received August 4, 2014

    Report

    Report Number
    3005011024-2014-00008
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 11, 2014
    Report Date
    August 1, 2014
    Manufacturer
    DEROYAL INDUSTRIES
    Product Code
    KDD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DREW AIR INTO SYRINGE EACH TIME THE DR. TRIED TO DRAW CONTRAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455530 ST. JOHN KIT KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL INDUSTRIES 35774516

    Patients

    Seq Age Sex Outcome Treatment
    1