BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER EXTENSION SET

    MDR report key: 6002736 · Received October 6, 2016

    Report

    Report Number
    6002736
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    January 6, 2016
    Report Date
    May 27, 2016
    Manufacturer
    BAXTER HEALTHCARE, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE IV TUBING BROKE IN HALF ABOVE THE EXTENSION SET WHILE INFUSING. THE PT HAD NOT MOVED OR CAUSED ANY DAMAGE TO TUBING TO CAUSE IT TO DETACH. BLOOD BACKED UP IN HER TUBING AND POURED ONTO HER BED. EXTENSION SET: 77288 A FLO: 77285 FROM BAXTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654929 BAXTER EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE, INC. DR15L14039

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR