BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL2BAG DC

    MDR report key: 7365237 · Received March 23, 2018

    Report

    Report Number
    7365237
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    March 12, 2018
    Report Date
    March 16, 2018
    Manufacturer
    MEDIMOP MEDICAL PROJECTS LTD.
    Product Code
    LHI
    UDI-DI
    07290108240054
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PULLED VIAL2BAG AND 250ML NS FROM MEDICATION PYXIS TO MIX LEVO DROPS. VIAL2BAG SYSTEM LEAKED AROUND VIAL AND CONTINUED TO LEAK AROUND THE VIAL EVEN AFTER MIXED. HAD TO PULL ANOTHER VIAL2BAG AND 250ML NS FROM PYXIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209730 VIAL2BAG DC SET, I.V. FLUID TRANSFER LHI MEDIMOP MEDICAL PROJECTS LTD. 6070112 07290108240054

    Patients

    Seq Age Sex Outcome Treatment
    1