BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL2BAG DC

    MDR report key: 7344659 · Received March 16, 2018

    Report

    Report Number
    7344659
    Event Type
    Malfunction
    Date Received
    March 16, 2018
    Date of Event
    February 23, 2018
    Report Date
    March 14, 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 NEEDLE WAS BENT. FOUND BY CATH LAB NURSE. DOES NOT SEEM TO BE DUE TO FORCEFUL CONNECTION UPON INSPECTION. BENT PLASTIC IS FIRM AND NOT "WOBBLY" AS MIGHT BE EXPECTED IF IT WAS BROKEN BY FORCE. MIGHT BE A MANUFACTURING ISSUE. MANUFACTURER RESPONSE FOR SET, I.V. FLUID TRANSFER, VIAL2BAG DC (PER SITE REPORTER): REP WAS MADE AWARE BY PHARMACY, UNKNOWN RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188799 VIAL2BAG DC SET, I.V. FLUID TRANSFER LHI MEDIMOP MEDICAL PROJECTS LTD. 6070112 07290108240054

    Patients

    Seq Age Sex Outcome Treatment
    1