BEUDAMED
    FDA Adverse Event Other Summary report: N

    3 GA INRM- MEDICAL WASTE 10

    MDR report key: 2997533 · Received March 4, 2013

    Report

    Report Number
    1424643-2013-00004
    Event Type
    Other
    Date Received
    March 4, 2013
    Report Date
    February 15, 2013
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
    Product Code
    MMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. 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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A MEDICAL WASTE DISPOSAL CONTAINER. THE CUSTOMER REPORTS WHEN STERICYCLE CAME TO TAKE THE CONTAINER AWAY FOR DESTRUCTION THEY WERE STUCK WITH A NEEDLE. THE NEEDLE WAS STICKING OUT DOWNWARD WHEN THE EMPLOYEE WENT TO GRAB THE SIDES OF THE CONTAINER. THE CUSTOMER DID INDICATE THAT SHE FOLLOWED THEIR NORMAL HOSPITAL PROTOCOL FOR A NEEDLE STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91323 3 GA INRM- MEDICAL WASTE 10 MEDICAL WASTE DISPOSAL CONTAINER MMK COVIDIEN LP, FORMERLY REGISTERED AS KENDALL 8522MW UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other