BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHARPS CONTAINER

    MDR report key: 2949585 · Received February 1, 2013

    Report

    Report Number
    2243072-2013-00002
    Event Type
    Other
    Date Received
    February 1, 2013
    Date of Event
    January 16, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BECTON DICKINSON
    Product Code
    KPE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURN IS ANTICIPATED AS COMPLAINT INDICATES THAT THE PRODUCT HAS BEEN DISCARDED. UNABLE TO RUN COMPLAINT HISTORY CHECK OR DEVICE HISTORY REVIEW AS LOT NUMBER IS UNKNOWN. SHARPS COLLECTORS ARE PUNCTURE RESISTANT. THEY ARE NOT, HOWEVER PUNCTURE PROOF. THEY ARE ROUTINELY CHECKED FOR WALL PENETRATION AND WALL THICKNESS. LABEL STATES THAT TO AVOID INJURY, EXAMINE THE COLLECTOR CAREFULLY BEFORE YOU FILL, CARRY, OR DISPOSE OF IT. QUALITY WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    PHARMACIST SUSTAINED A NEEDLE STICK ON FINGER FROM USED NEEDLE PROTRUDING FROM THE BOTTOM OF A SHARPS CONTAINER. HE HAD BLOOD WORK SCHEDULED AND WILL VISIT DOCTOR IN ONE MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44213 SHARPS CONTAINER SHARPS CONTAINER KPE BECTON DICKINSON

    Patients

    Seq Age Sex Outcome Treatment
    1 Other