BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHARPS-A-GATOR

    MDR report key: 128703 · Received October 24, 1997

    Report

    Report Number
    1062224-1997-00003
    Event Type
    Other
    Date Received
    October 24, 1997
    Date of Event
    April 23, 1997
    Report Date
    May 6, 1997
    Manufacturer
    GRAPHIC CONTROLS
    Product Code
    MMK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A TRAINED HOUSEKEEPER EXPERIENCED A NEEDLE STICK INJURY TO THE FINGER WHEN ATTEMPTING TO CLOSE THE LID OF A SAG 4808 7 1/2 GALLON RED SHARPS CONTAINER WHICH WAS APPROXIMATELY 2/3'S FULL. SOMETHING LARGE. SUCH AS A SPINAL NEEDLE, WAS STUCK DURING THE LID CLOSURE. THE CUSTOMER FEELS THE LIDS ARE TOO HARD TO CLOSE. THERE WERE NO DIRECTIONS FOR USE FOR THIS PRODUCT TO ADVISE ASSEMBLY OF LID PRIOR TO USE. THE HOUSEKEEPER WAS GIVEN HIV COUNSELING AND REFERRED TO AN HIV COUNSELOR AT THE HEALTH DEPT FOR F/U. THE HOUSEKEEPER WAS WORKING AND REPORTABLY FINE AT THE TIME OF THE INCIDENT INVESTIGATION ON 5/7/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPS-A-GATOR GENERAL PURPOSE SHARPS CONTAINER MMK GRAPHIC CONTROLS 4808 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other