BEUDAMED
    FDA Adverse Event Other Summary report: N

    1 QT N/S CONTAINER RED 100

    MDR report key: 3913920 · Received June 6, 2014

    Report

    Report Number
    1424643-2014-00007
    Event Type
    Other
    Date Received
    June 6, 2014
    Report Date
    May 30, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2014. 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) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A SHARPS CONTAINER. THE CUSTOMER REPORTS THAT WHEN PICKING UP THE SHARPS CONTAINER AN EMPLOYEE WAS STUCK WITH A DIRTY NEEDLE STICK. THE CUSTOMER FURTHER REPORTS THAT THE CONTAINER WAS PICKED UP AND PLACED IN THE INSIDE OF THE ARM (LIKE CARRYING SOMETHING), AND THE NEEDLE PUNCTURED THROUGH THE SIDE OF THE CONTAINER AND THE EMPLOYEE WAS STRUCK ON THE INSIDE OF THE FOREARM. THE EMPLOYEE IS GOING THROUGH THEIR FACILITIES PROTOCOL AND THEY HAVE ALSO HAD BLOOD DRAWN UP FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331409 1 QT N/S CONTAINER RED 100 SHARPS CONTAINER MMK COVIDIEN 8900SA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other