BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVIA EMPTY BAG 150ML

    MDR report key: 6098917 · Received November 10, 2016

    Report

    Report Number
    MW5065971
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Report Date
    November 9, 2016
    Manufacturer
    BAXTER
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    WITHIN THE LAST 3 MONTHS OUR HOSPITAL PHARMACY HAS NOTICED CORES AND PIECES OF PLASTIC IN BAXTER INTRAVIA EMPTY BAGS IN 150, 250, AND 500 ML SIZES. IT HAS HAPPENED IN ABOUT 10 BAGS OF NON-HAZARDOUS MEDICATIONS THAT WERE SPIKED WITH REGULAR SPIKES. IN ADDITION, THERE WERE 3 BAGS THAT CLEARLY HAD THESE PLASTIC PLUGS THAT WERE PENETRATED WITH PHASEAL (BD CLOSED SYSTEM) SPIKES. THERE MAY BE ADDITIONAL BAGS BUT THEY MAY HAVE BEEN DISCARDED. BAGS WITH PHASEAL SPIKES WERE INTRAVIA 150 ML SIZE (ITEM # 2B8011 LOT 15L14059 AND DR 16E13061). THESE BAGS WERE SENT FOR EVALUATION TO MANUFACTURER AFTER CONTACTING MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745121 INTRAVIA EMPTY BAG 150ML INTRAVIA EMPTY BAG 150ML KPE BAXTER DR15L14059
    745122 INTRAVIA EMPTY BAG 250ML INTRAVIA EMPTY BAG 250ML KPE BAXTER UR15L09125
    745123 INTRAVIA EMPTY BAG 500ML INTRAVIA EMPTY BAG 500ML KPE BAXTER DR16C18057
    745126 INTRAVIA EMPTY BAG 150ML INTRAVIA EMPTY BAG 150ML KPE BAXTER DR15K17054
    745127 INTRAVIA EMPTY BAG 150ML INTRAVIA EMPTY BAG 150ML KPE BAXTER DR16E13061
    745128 INTRAVIA EMPTY BAG 500ML INTRAVIA EMPTY BAG 500ML KPE BAXTER DR16F07038

    Patients

    Seq Age Sex Outcome Treatment
    1