BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESURE INFUSION BAG

    MDR report key: 3966433 · Received June 25, 2014

    Report

    Report Number
    1721504-2014-00125
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: NOTHING IS EXPECTED TO BE RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE PRESSURE INFUSION BAG FOR AN ARTERIAL LINE SLOWLY DEFLATED OVER 10 MINUTES. THE BAG WAS REPLACED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370635 PRESURE INFUSION BAG INFUSOR, PRESSUER, FOR I.V. BAGS KZD MERIT MEDICAL SYSTEMS, INC. I668545

    Patients

    Seq Age Sex Outcome Treatment
    1