BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH SOLUTION TRANSFER SET (SHORT) - JAPAN

    MDR report key: 1122192 · Received August 15, 2008

    Report

    Report Number
    1423500-2008-00747
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 29, 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 A BROKEN SPIKE ON A TRANSFER SET. HAD BEEN IN USE FOR 80 DAYS. 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