BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAXTER

    MDR report key: 793051 · Received December 11, 2006

    Report

    Report Number
    MW1041328
    Event Type
    Other
    Date Received
    December 11, 2006
    Date of Event
    December 10, 2006
    Report Date
    December 11, 2006
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ON 12/08/06, PREPARED HYDROMORPHONE 1MG/1ML IN NS, PREPARED 1 250ML BAG; CONTENTS =250MG HYDROMORPHONE IN A TOTAL OF 250ML NS, FINAL CONCENTRATION - 1MG/1ML. EMPTY CONTAINER WAS A INTRAVIA EMPTY CONTAINER PRODUCED BY BAXTER PRODUCT #2B8012 LOT- UR337071. ON 12/10/06, NURSE HOOKED UP PT AND LEFT HOME, SEVERAL HOURS LATER PT'S DAUGHTER CALLED TO SAY BAG WAS LEAKING, BAG WAS REPLACED. ON 12/11/06 HAD LEAKING BAG RETURNED TO HOME HEALTH CO BRANCH, WHERE IT WAS DISCOVERED THAT BOTH BAG PORTS-ADDITIVE PORT AND INFUSION PORT WERE LOOSE AND COULD BE EASILY REMOVED FROM BAG BY GENTLE TWISTING, NOTIFIED BAXTER OF EVENT AND EVENT WAS ASSIGNED TRACKING #. THE CONTAINER DID NOT SHOW ANY SIGNS OF TAMPERING. I AM CONCERNED IF THIS IS A MANUFACTURING DEFECT THAT OTHER BAGS COULD BECOME CONTAMINED AND CAUSE PT HARM, ASSUMING THIS DEFECT IS PRESENT IN OTHER BAGS OF THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER INTRAVIA EMPTY CONTAINER 250ML KPE BAXTER HEALTHCARE INTRAVIA EMPTY UR337071

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other