BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE EMPTY EVA CONTAINER

    MDR report key: 1980209 · Received January 31, 2011

    Report

    Report Number
    MW5019267
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 31, 2011
    Manufacturer
    THE METRIX COMPANY
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    SPIKE PORT OF IV BAG SEPARATED FROM BAG AFTER BAG WAS SPIKED RESULTING IN IV MEDICATION (NICARDIPINE) RUNNING ONTO FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE EMPTY EVA CONTAINER IV BAG KPE THE METRIX COMPANY 250 ML 5228
    2 BAXTER IV TUBING IV TUBING FPA BAXTER

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other