BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH

    MDR report key: 1230746 · Received November 17, 2008

    Report

    Report Number
    1423500-2007-00103
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    February 5, 2007
    Report Date
    February 6, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BAXTER PRODUCT SURVEILLANCE RECEIVED NOTIFICATION OF AN INCIDENT FROM THE INTERNATIONAL AFFILIATE IN 2007. INT'L AFFILIATE REPORTED A BROKEN SPIKE AFTER 60 DAYS OF USE. THE SAMPLE IS AVAILABLE AND HAS BEEN REQUESTED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS INCIDENT PER THE INTERNATIONAL AFFILIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPD SOLUTION TRANSFER SET (SHORT) FOR UV-FLASH UV TRANSFER SETS KDJ BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1