BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTA-MIX 100ML EVA CONTAINER

    MDR report key: 1531952 · Received November 12, 2009

    Report

    Report Number
    MW5013515
    Event Type
    Injury
    Date Received
    November 12, 2009
    Date of Event
    November 11, 2009
    Report Date
    November 12, 2009
    Manufacturer
    BAXA CORPORATION
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    BAXA EXACTA-MIX COMPOUNDER BAGS HAD TWO ADMINISTRATION PORT FAILURES WHEN NURSES ATTEMPTED TO SPIKE PARENTERAL NUTRITION ADMIXTURES FOR ADMINISTRATION. THE ADMINISTRATION PORTS BECAME UNATTACHED FROM THE BAG AND THE CONTENTS RAN OUT UNIMPEDED. THIS IS NOT ONLY A DOSAGE ADMINISTRATION RISK, BUT AN INFECTION CONTROL RISK. ADDITIONALLY, CHEMOTHERAPEUTIC AGENTS ARE COMMONLY COMPOUNDED IN THESE BAGS AND SUCH A FAILURE WOULD CREATE SIGNIFICANT PERSONNEL AND ENVIRONMENTAL RISKS. THE BAG DESIGN IS NEW TO THIS MARKET AND THE COMPANY HAS BEEN NOTIFIED OF THE DESIGN FAILURE. DATES OF USE: 2009. DIAGNOSIS: INFUSION COMPOUNDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX 100ML EVA CONTAINER EVA CONTAINER KPE BAXA CORPORATION 738176

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability