BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL2BAG DC

    MDR report key: 7365323 · Received March 23, 2018

    Report

    Report Number
    7365323
    Event Type
    Malfunction
    Date Received
    March 23, 2018
    Date of Event
    February 27, 2018
    Report Date
    March 9, 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

    VIAL2BAG CONNECTOR WAS LEAKING. LEAK DID NOT OCCUR AT ANY CONNECTION SITES (I.E. NOT WHERE THE VIAL WAS SPIKED OR WHERE THE TUBING WAS SPIKED), BUT RATHER WITHIN THE CONNECTOR ITSELF. POSSIBLY DUE TO MANUFACTURER DEFECT. SAMPLE WAS PROVIDED TO REP BY PHARMACY. MANUFACTURER RESPONSE FOR SET, I.V. FLUID TRANSFER, VIAL2BAG DC (PER SITE REPORTER) PROVIDED TO REP BY PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209947 VIAL2BAG DC SET, I.V. FLUID TRANSFER LHI MEDIMOP MEDICAL PROJECTS LTD. 6070112 07290108240054

    Patients

    Seq Age Sex Outcome Treatment
    1