BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH SOLUTION TRANSFER SET (SHORT)-JAPAN

    MDR report key: 1071538 · Received July 3, 2008

    Report

    Report Number
    1423500-2008-00606
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 18, 2008
    Report Date
    June 23, 2008
    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

    BAXTER REPORTED THAT THE SPIKE FOR THE TRANSFER SET WAS BROKEN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1