BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK VENTED PACLTAXEL SET

    MDR report key: 1241692 · Received November 25, 2008

    Report

    Report Number
    6000001-2007-01970
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    January 16, 2007
    Report Date
    January 17, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE HAS BEEN DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION. THE MANUFACTURING FACILITY HAS BEEN MADE AWARE OF THIS REPORT THROUGH BAXTER'S COMPLAINT MANAGEMENT TRACKING SYSTEM. THE MANUFACTURING FACILITY WILL CONTINUE TO MONITOR SIMILAR REPORTS FOR POSSIBLE TRENDS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED FROM BAXTER SALES REP. CUSTOMER REPORTS THAT THE TUBING SEPARATED JUST BELOW THE DRIP CHAMBER DURING USE, RESULTING IN A SPILL OF CHEMOTHERAPY DRUG. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK VENTED PACLTAXEL SET CLEARLINK FPA BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1