BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE INFUSION BAG

    MDR report key: 3966435 · Received June 25, 2014

    Report

    Report Number
    1721504-2014-00124
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    KZD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER REPORTED A SECOND LOT NUMBER (I677857) WITH A MANUFACTURING DATE OF 04/18/2014 AND AN EXPIRATION DATE OF 03/31/2014. DEVICE EVALUATION: THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRESSURE INFUSION BAG SLOWLY DEFLATED. THE BAG WAS EXCHANGED FOR A NEW DEVICE WHEN THIS WAS DISCOVERED. NO CLINICAL INFORMATION WAS PROVIDED BY THE CUSTOMER. MULTIPLE ATTEMPTS WERE MADE TO GAIN THIS INFORMATION WITHOUT SUCCESS. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370521 PRESSURE INFUSION BAG INFUSOR, PRESSURE, FOR I.V. BAGS KZD MERIT MEDICAL SYSTEMS, INC. I668545

    Patients

    Seq Age Sex Outcome Treatment
    1