BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    250E NDL 23 X 1 A

    MDR report key: 1213998 · Received October 20, 2008

    Report

    Report Number
    1017768-2008-00025
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    October 5, 2008
    Report Date
    October 20, 2008
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 10/21/2008. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN IN 2008, THAT A CUSTOMER HAD AN ISSUE WITH A NEEDLE WHILE TRANSFERRING BLOOD INTO A TUBE. THE CUSTOMER REPORTS THE NEEDLE IS COMING LOOSE FROM THE HUB. CUSTOMER STATES AFTER THE VENIPUNCTURE AND AS THEY ARE TRANSFERRING THE BLOOD TO THE VACUTAINER TUBE, THE NEEDLE DETACHED FROM THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 250E NDL 23 X 1 A NEEDLE FMI COVIDIEN 8881250255 821809

    Patients

    Seq Age Sex Outcome Treatment
    1 NA