BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE INFUSION BAG

    MDR report key: 4093204 · Received August 21, 2014

    Report

    Report Number
    1721504-2014-00181
    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

    DEVICE EVAL: ONE USED DEVICE WAS RETURNED FOR EVAL. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO EXCEPTION DOCUMENTS WERE FOUND. THE COMPLAINT DATABASE WAS REVIEWED AND ONE SIMILAR COMPLAINT FOR THIS LOT NUMBER WAS FOUND. THE BAG WAS PRESSURE TESTED AND FAILED THE PRESSURE TEST. THE FAILURE WAS ATTRIBUTED TO THE BOND BETWEEN THE TUBING AND THE BAG. THE COMPLAINT IS CONFIRMED. 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 PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506609 PRESSURE INFUSION BAG INFUSOR, PRESSURE, FOR I.V. BAGS KZD MERIT MEDICAL SYSTEMS, INC. I668544

    Patients

    Seq Age Sex Outcome Treatment
    1