BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 QT N/S CONTAINER RED 100

    MDR report key: 1463069 · Received July 14, 2009

    Report

    Report Number
    1424643-2009-00003
    Event Type
    Malfunction
    Date Received
    July 14, 2009
    Date of Event
    June 30, 2009
    Report Date
    July 7, 2009
    Manufacturer
    COVIDIEN
    Product Code
    MMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 07/07/2009, THAT A CUSTOMER HAD AN ISSUE WITH A SHARPS CONTAINER. THE CUSTOMER STATED A NEEDLE PUNCTURED THROUGH THE SHARPS CONTAINER IN THE LOWER BOTTOM HALF OF THE CONTAINER. THE CLINICIAN WENT TO PICK UP THE CONTAINER AND THE NEEDLE WAS STICKING OUT, AND STUCK CLINICIAN IN THE ARM. CUSTOMER REPORTS IT WAS A LARGE HOLE, SO THEY BELIEVE IT WAS AN 18G NEEDLE. WHEN THE EDUCATION DEPT SAW THE CONTAINER SHE SAID IT WAS VERY FULL. CLINICIAN STATED SHE HAD TO FORCE SHARPS INTO THE CONTAINER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK