BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK VENTED PACLITAXEL SET

    MDR report key: 549468 · Received April 7, 2004

    Report

    Report Number
    6000001-2004-00595
    Event Type
    Malfunction
    Date Received
    April 7, 2004
    Date of Event
    March 1, 2004
    Report Date
    March 26, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE FACILITY HAS REPORTED THAT THE SPIKE/PORT INTERFACE IS NOT TIGHT AND LEAKS. THE SET IS BEING SPIKED INTO A B-BRAUN 250ML NON-PVC SOLUTION BAG. TAXOL IS BEING USED AND IS LEAKING FROM THE CONNECTION. THE FACILITY HAD NO PROBLEMS WHEN USING INTERLINK SETS/SPIKES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK VENTED PACLITAXEL SET CLEARLINK FPA BAXTER HEALTHCARE CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN