BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL2BAG DC 20MM

    MDR report key: 7518245 · Received May 15, 2018

    Report

    Report Number
    MW5077253
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Date of Event
    May 6, 2018
    Report Date
    May 10, 2018
    Manufacturer
    MEDIMOP MEDICAL PROJECTS LTD.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DEVICE FAILURE. THIS DEVICE IS VERY DEPENDENT ON USER USING CORRECT TECHNIQUE, BUT WE HAD A REPORT OF INCREASED FAILURE RATES OR CERTAIN LOT NUMBER. WE ARE TRACKING ALL FAILURES TO SEE IF IT IS A PERCEIVED INCREASE OR ACTUAL INCREASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358488 VIAL2BAG DC 20MM SET, IV FLUID TRANSFER LHI MEDIMOP MEDICAL PROJECTS LTD. 6070112 A001

    Patients

    Seq Age Sex Outcome Treatment
    1