BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE INFUSION BAG

    MDR report key: 3966432 · Received June 25, 2014

    Report

    Report Number
    1721504-2014-00126
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    KZD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: 48 UNUSED UNITS 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 IS LOOSING PRESSURE. NO HARM OR INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370520 PRESSURE INFUSION BAG INFUSOR, PRESSURE, FOR I.V. BAGS KZD MERIT MEDICAL SYSTEMS, INC. I668545

    Patients

    Seq Age Sex Outcome Treatment
    1