BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED PACLITAXEL SET W/POLYTBG NON-DEHP PUM SEGMENT 22F

    MDR report key: 1062805 · Received June 17, 2008

    Report

    Report Number
    6000001-2008-00379
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 3, 2008
    Manufacturer
    BAXTER CARTAGO
    Product Code
    FPA
    PMA / PMN Number
    K984381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS PERFORMED AND THE REPORTED ISSUE OF A LEAKING LUER LOCK WAS NOT DETECTED IN THE SAMPLES. THE DEFECT WAS NOT CONFIRMED. HOWEVER, AN ENGINEERING REVIEW DETERMINED THAT THE PROBABLE CAUSE IS ASSOCIATED WITH CRACKED/BROKEN MALE LUER.

    Description of Event or Problem · 1

    BAXTER REPORTED A LEAKING LUER LOCK CONNECTION WITH THIRTY-FOUR (34) UNITS OF THE VENTED PACLITAXEL SET, PRODUCT CODE 2C8857, LOT NUMBER R07B07020. IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. HOWEVER, THERE WAS NO PATIENT INVOLVEMENT OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED PACLITAXEL SET W/POLYTBG NON-DEHP PUM SEGMENT 22F 80FPA FPA BAXTER CARTAGO NA R07B07020

    Patients

    Seq Age Sex Outcome Treatment
    1