BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK PACLITAXEL SET

    MDR report key: 1240293 · Received November 24, 2008

    Report

    Report Number
    6000001-2007-02138
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    January 16, 2007
    Report Date
    January 16, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN REQUESTED FOR EVALAUTION. IF DEVICE IS RECIEVED AND AN EVALUATION PERFORMED, A FOLLOW-UP MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT AN INCIDENT WHERE THE TUBING AND DRIP CHAMBER SEPARATED DURING SET UP PATIENTS TREATMENT. NO PATIENT INJURY HAS BEEN REPORTED AT THIS TIME. TAXOL SPLASHED ON NURSE. NURSE NEEDED TO CHANGE HER UNIFORM. CUSTOMER REPORTED NURSE WENT HOME AFTER SPILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK PACLITAXEL SET INTRAVASCULAR ADMINISTRATION SET FPA BAXTER HEALTHCARE CORPORATION N/A R06F22013

    Patients

    Seq Age Sex Outcome Treatment
    1