BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHARPS CONTAINER, 1 QT, RED

    MDR report key: 753809 · Received August 17, 2006

    Report

    Report Number
    1417592-2006-00015
    Event Type
    Injury
    Date Received
    August 17, 2006
    Report Date
    July 25, 2006
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    MMK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SHARPS CONTAINER WAS MANUFACTURED FOR MAXXIM MEDICAL BY MEDICAL ACTION PRIOR TO ACQUISITION OF MAXXIM MEDICAL. MEDLINE NO LONGER DISTRIBUTES PRODUCT MADE BY THIS MANUFACTURER. THE HOME CARE HAS DECLINED TO SEND THE SHARPS CONTAINER TO US FOR INVESTIGATION. THE REPORT SOURCE STATES SHE DOES NOT KNOWN IF THE CONTAINER WAS FILLED ABOVE THE FILL LINE AS THE CONTAINER IS LOCKED SHUT AND THEY CANNOT SEE INSIDE THE CONTAINER. THE CUSTOMER HAS PROVIDED DIGITAL PHOTOGRAPHS OF THE CONTAINER, WHICH HAS A NEEDLE PROTRUDING THROUGH FRONT OF THE CONTAINER APPROXIMATELY 1/4 INCH AND AT A DOWNWARD ANGLE. THE PUNCTURE SITE IS APPROXIMATELY 5 INCHES FROM THE TOP OF THE CONTAINER. WITHOUT RETURN OF THE PRODUCT, AN ANALYSIS CANNOT BE COMPLETED AND NO EVALUATION CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A NURSE WAS REPORTEDLY STUCK BY A USED NEEDLE THAT HAD POKED THROUGH THE SIDE OF THE SHARPS CONTAINER. THE SHARPS CONTAINER FOR THE HOME HEALTH CARE FACILITY RESIDES ON A SHELF IN THE SUPERVISOR'S OFFICE. THE CONTAINER WAS FULL, SO THE NURSE LOCKED THE CLOSURE LID DOWN AND WHEN SHE PICKED THE CONTAINER UP TO TAKE IT TO THE BIOHAZARDS DISPOSAL AREA, SHE RECEIVED A NEEDLESTICK TO THE RIGHT THUMB. SHE WAS SEEN IN AN EMERGENCY ROOM WHERE HEPATITIS AND HIV LABS WERE DRAWN. SHE RECEIVED TETANUS AND HEPATITIS B BOOSTER SHOTS. SHE WAS PRESCRIBED COMBIVIR TWICE DAILY FOR 28 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPS CONTAINER, 1 QT, RED SHARPS CONTAINER MMK MEDLINE INDUSTRIES, INC. MDS709110 99292023

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention