BEUDAMED
    FDA Adverse Event Other Summary report: N

    3 GA INRM TRNS RD CLR TOP 10

    MDR report key: 2849267 · Received November 14, 2012

    Report

    Report Number
    1424643-2012-00006
    Event Type
    Other
    Date Received
    November 14, 2012
    Report Date
    November 7, 2012
    Manufacturer
    COVIDIEN
    Product Code
    MMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 (B)(4) 2012, THAT A CUSTOMER HAD AN ISSUE WITH A SHARPS DISPOSAL CONTAINER. THE CUSTOMER REPORTS THE NURSE GRABBED THE CONTAINER, AND HAD BOTH ARMS AROUND IT. A NEEDLE WAS STICKING OUT OF THE SIDE WITH THE LABEL ON IT AND STUCK THE NURSES ARM NEAR HER ELBOW. THE NURSE FOLLOWED NORMAL HOSPITAL PROTOCOL FOR A NEEDLE STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 GA INRM TRNS RD CLR TOP 10 SHARPS DISPOSAL CONTAINER MMK COVIDIEN 85221R UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other