BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVIA CONTAINER 150ML

    MDR report key: 3873887 · Received May 29, 2014

    Report

    Report Number
    3873887
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    February 27, 2014
    Report Date
    May 23, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    REPORT FROM RN EXPERIENCING THIS ISSUE: SEVERAL INTRAVENOUS PIGGYBACKS (IVPB) HAVE BEEN HUNG AND IT IS IMPOSSIBLE TO REMOVE THE SPIKE FROM THE PIGGYBACK TO HANG A NEW ONE. YOU CAN PULL AND IT WILL NOT COME OUT, IT HAS EVEN BEEN TORN AND COMPROMISED TRYING TO GET THE SPIKE OUT. THIS MORNING THE PREVIOUS RN COULD NOT REMOVE THE SPIKE FROM VANCOMYCIN TO BE ABLE TO HANG THE NEXT DOSE AND DUE TO THIS, I HAD TO HANG THE DOSE AFTER OBTAINING NEW TUBING AND ACCESSING THE CENTRAL LINE AN EXTRA TIME. THEN THIS AFTERNOON I HUNG POTASSIUM IN AN IVPB AND IT WAS IMPOSSIBLE TO REMOVE THE SPIKE FROM THE BAG TO HANG THE NEXT DOSE. DUE TO THIS, THE PATIENT HAS NEEDED TO GET NEW TUBING SEVERAL TIMES WHICH MEANS ACCESSING THE LINE MORE FREQUENTLY AGAIN FOR THIS DRUG AS WELL. ALSO, PRIOR TO SPIKING THE POTASSIUM IN THE IVPB BAG, IT WAS DIFFICULT TO REMOVE THE BLUE PLASTIC PIECE THAT COVERS THE INSERTION AREA TO SPIKE THE MEDICATION. I HAD TO PRY IT OFF AND THERE WAS SOME CLEAR GLUE HOLDING THIS PIECE ON. IT WAS SO HARD TO REMOVE THAT I WAS CONCERNED ABOUT THE STERILITY OF THE MEDICATION IF IT IS THAT DIFFICULT TO OPEN TO EVEN SPIKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316898 INTRAVIA CONTAINER 150ML CONTAINER, I.V. KPE BAXTER HEALTHCARE CORPORATION N/A UR13KO7123

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR NOT APPLICABLE.