BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH SOLUTION TRANSFER SET(SHORT)-JAPAN

    MDR report key: 1230193 · Received November 17, 2008

    Report

    Report Number
    1423500-2007-88849
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    June 12, 2007
    Report Date
    June 14, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K883239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INT'L AFFILIATE REPORTED BROKEN SPIKE ON A TRANSFER SET. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-FLASH SOLUTION TRANSFER SET(SHORT)-JAPAN TRANFER SET / 78KDJ KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1