BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTA MIX EVA CONTAINER

    MDR report key: 1515389 · Received October 20, 2009

    Report

    Report Number
    MW5013141
    Event Type
    Malfunction
    Date Received
    October 20, 2009
    Date of Event
    October 18, 2009
    Report Date
    October 20, 2009
    Manufacturer
    BAXA CORPORATION
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WE USE A BAXA TPN COMPOUNDER. WITH THIS MACHINE, WE USE TPN BAGS - BAXA EXACTA MIX EVA CONTAINERS - PROVIDED BY THE MFR. WE WERE RECENTLY INFORMED THAT THEY WERE SWITCHING TO A NEW STYLE OF BAG. WE STARTED TO RECEIVE THESE NEW BAGS IN THE 2,000 ML SIZE. A VERY HIGH PERCENTAGE - ABOUT 10% - LEAK. THEY LEAK AROUND THE PORT THAT THE IV ADMINISTRATION SET WILL PLUG INTO. THIS IS ONLY AN ISSUE PRIOR TO THE SPIKING OF THE BAG. HOWEVER, WE FEEL THAT THE STERILITY OF THE BAG IS BEING COMPROMISED. THE COMPANY WAS NOTIFIED AND THEY STATED THAT 'ISSUES" WERE BEING REPORTED BY OTHER USERS AS WELL. DATES OF USE: 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA MIX EVA CONTAINER TPN BAG KPE BAXA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1