BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE INFUSION BAG

    MDR report key: 4190040 · Received September 18, 2014

    Report

    Report Number
    1721504-2014-00222
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    KZD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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

    THE USER REPORTED THAT THE PRESSURE INFUSION BAG IS LOSING PRESSURE AFTER BEING INFLATED. THIS WAS DISCOVERED DURING AN INTERNAL EVALUATION DONE BY THE HOSPITAL. THE DEVICE WAS NOT USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577756 PRESSURE INFUSION BAG INFUSOR, PRESSURE, FOR I.V. BAGS KZD MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1