BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 GAL FISHER SHARPS CONTAINER

    MDR report key: 2221895 · Received August 17, 2011

    Report

    Report Number
    1424643-2011-00005
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    May 4, 2011
    Report Date
    August 15, 2011
    Manufacturer
    COVIDIEN
    Product Code
    MMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A SHARPS CONTAINER. THE END USER REPORTS THAT AN EMPLOYEE RECEIVED A DIRTY NEEDLE STICK FROM A NEEDLE PROTRUDING OUT FROM UNDER THE LID OF THE CONTAINER. THE EMPLOYEE WAS WEARING TWO PAIRS OF PROTECTIVE GLOVES, AND THE NEEDLE PIERCED BOTH GLOVES. IN RESPONSE, THE EMPLOYEE UNDERWENT BLOOD BORNE PATHOGEN TESTING, WHICH INCLUDED BASELINE TESTING WITH A FOLLOW UP SCHEDULED AT 6 MONTHS FROM THE DATE OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1 GAL FISHER SHARPS CONTAINER SHARPS CONTAINER MMK COVIDIEN 31157111 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN