BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2957100 · Received December 31, 2012

    Report

    Report Number
    2957100
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Date of Event
    December 19, 2012
    Report Date
    December 31, 2012
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    OJA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAFF MEMBER REPORTS SEVERAL MANIFOLD KITS HAVE BEEN FOUND BROKEN PRIOR TO USE. LEAKING SALINE WAS NOTICED AND/OR BLEED BACK IN THE SHEATH FROM THE PRESSURE LINE. THEN STAFF BEGAN ASSESSING THEM BEFORE USE AND FOUND CRACKS. INITIALLY ONLY ONE LOT NUMBER WAS INVOLVED AND IT WAS REMOVED FROM USE. TODAY A SECOND LOT NUMBER WAS NOTED TO BE BROKEN AGAIN AT A LUER ATTACHMENT BY MANUFACTURER.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?DEVICE TO BE USED FOR CARDIAC CATHETER TO OBTIAN PRESSURES, OBTAIN SPECIMENS AND ADMINISTER FLUIDS.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NODEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ADAPTOR, STOPCOCK, MANIFOLD OJA ARGON MEDICAL DEVICES INC. * 11026454
    2 * ADAPTOR, STOPCOCK, MANIFOLD DTL ARGON MEDICAL DEVICES INC. * 11028628

    Patients

    Seq Age Sex Outcome Treatment
    1 *