BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL ADAPTOR

    MDR report key: 7384771 · Received March 30, 2018

    Report

    Report Number
    7384771
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    March 27, 2018
    Report Date
    March 28, 2018
    Manufacturer
    MEDIMOP MEDICAL PROJECTS LTD.
    Product Code
    LHI
    UDI-DI
    07290108240160
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WITHIN THE PRODUCT BYDUREON, THERE IS A DEVICE CALLED A VIAL CONNECTOR THAT IS USED TO RECONSTITUTE THE MEDICATION. WHEN THIS WAS OPENED FOR USE, THE VIAL CONNECTOR WAS DAMAGED. THE SPIKE WAS BENT AT A 90 DEGREE ANGLE. THIS HAS HAPPENED BEFORE ABOUT 6 MONTHS AGO. MANUFACTURER RESPONSE FOR SET, I.V. FLUID TRANSFER, VIAL ADAPTOR (PER SITE REPORTER). PRODUCT BEING REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228025 VIAL ADAPTOR SET, I.V. FLUID TRANSFER LHI MEDIMOP MEDICAL PROJECTS LTD. 8070301 JF0265 07290108240160

    Patients

    Seq Age Sex Outcome Treatment
    1 NO| NO OTHER THERAPIES.