BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGELLAN SAFE BC HLDR 1.25X22G

    MDR report key: 1243095 · Received November 21, 2008

    Report

    Report Number
    1650158-2008-00012
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    July 14, 2008
    Report Date
    October 28, 2008
    Manufacturer
    COVIDIEN
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 10/28/2008 THAT A CUSTOMER HAD AN ISSUE WITH A BLOOD COLLECTION DEVICE. THE CUSTOMER REPORTS THE NEEDLE CAME APART FROM HOLDER WHILE IN PATIENT'S ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGELLAN SAFE BC HLDR 1.25X22G BLOOD COLLECTION DEVICE JKA COVIDIEN 8881226122 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK