BEUDAMED
    FDA Adverse Event Other Summary report: N

    3 GA SHARPSTAR II CONT CLR 10

    MDR report key: 3391395 · Received September 26, 2013

    Report

    Report Number
    1424643-2013-00008
    Event Type
    Other
    Date Received
    September 26, 2013
    Date of Event
    August 26, 2013
    Report Date
    September 5, 2013
    Manufacturer
    COVIDIEN
    Product Code
    MMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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)(4) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A SHARPS CONTAINER. THE CUSTOMER REPORTS THAT THE SHARPS CONTAINER WAS REMOVED FROM THE WALL ENCLOSURE FOR REPLACEMENT AND IN DOING SO, THE NURSE WAS STUCK BY A USED NEEDLE DUE TO A LARGE CRACK IN THE BOTTOM. THE NURSE WAS STUCK IN THE HAND AND WAS BEING TREATED FOR THE NEEDLE STICK PER THE HOSPITAL PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487730 3 GA SHARPSTAR II CONT CLR 10 SHARPS CONTAINER MMK COVIDIEN 8636SA (10) 132012X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other