BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE INFUSION BAG

    MDR report key: 4093207 · Received August 21, 2014

    Report

    Report Number
    1721504-2014-00188
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    KZD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO EXCEPTION DOCUMENTS WERE FOUND. THE COMPLAINT DEVICE WAS REVIEWED AND ONE SIMILAR COMPLAINT FOR THIS LOT NUMBER WAS FOUND. BECAUSE THE UNIT WAS NOT RETURNED, THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE DEVICE IS RETURNED IN THE FUTURE THIS INVESTIGATION WILL BE REOPENED AND FOLLOW UP SUBMITTED. A SUPPLIER CORRECTIVE ACTION HAS BEEN REQUESTED FROM THE MANUFACTURER.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE PRESSURE INFUSION BAG IS LOSING PRESSURE DURING THE INITIAL USE. THE LEAK WAS DISCOVERED BEFORE THE PROCEDURE BEGAN. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504653 PRESSURE INFUSION BAG INFUSOR, PRESSURE, FOR I.V. BAGS KZD MERIT MEDICAL SYSTEMS, INC. I668544

    Patients

    Seq Age Sex Outcome Treatment
    1