BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERLINK VENTED PACLITAXEL SET

    MDR report key: 532395 · Received March 4, 2004

    Report

    Report Number
    6000001-2004-00378
    Event Type
    Other
    Date Received
    March 4, 2004
    Date of Event
    February 2, 2004
    Report Date
    February 5, 2004
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THREE INCIDENTS OF LEAKAGE AT THE FILTER AIR VENT. REPORTEDLY, TWO INCIDENTS OCCURRED DURING PT USE AND ONE DURING PRIMING. ONE OF THE DRUGS THAT LEAKED WAS AN INVESTIGATIONAL DRUG AND ANOTHER ONE WAS CHEMO DRUG CALLED TAXOL. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK VENTED PACLITAXEL SET SOLUTION ADMINISTRATION SET FPA BAXTER HEALTHCARE CORP. NA UR189407

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN TAXOL