BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2 GA H-DROP CLR LID RED 20

    MDR report key: 2352532 · Received November 14, 2011

    Report

    Report Number
    1424643-2011-00010
    Event Type
    Malfunction
    Date Received
    November 14, 2011
    Date of Event
    October 21, 2011
    Report Date
    October 27, 2011
    Manufacturer
    COVIDIEN
    Product Code
    MMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A SHARPS CONTAINER. THE CUSTOMER STATES WHEN HE HELD THE PRODUCT, HE FELT PAIN ON THE LEFT PALM BECAUSE A NEEDLE HAD PENETRATED THE BOTTOM. THE CONTAINER WAS USED FOR NEEDLES WHICH HAD NOT BEEN UTILIZED FOR PTS, THEREFORE, THIS EVENT WAS THOUGHT TO BE SAFE FROM INFECTION. THE EMPLOYEE DID HAVE BLOOD DRAWN AND ALL TESTS CAME BACK NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2 GA H-DROP CLR LID RED 20 SHARPS CONTAINER MMK COVIDIEN 89651 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK