BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHARPS CONTAINER

    MDR report key: 53091 · Received December 3, 1996

    Report

    Report Number
    MW1010355
    Event Type
    Other
    Date Received
    December 3, 1996
    Date of Event
    July 3, 1996
    Report Date
    December 3, 1996
    Manufacturer
    SAGE PRODUCTS, INC.
    Product Code
    MMK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    USER WAS LIFTING A SHARPS CONTAINER FROM THEIR SECONDARY TRANSPORT BAG AND FELT A STICK. UPON EXAMINATION OF THE SHARPS CONTAINER A PUNCTURE HOLE WAS NOTED. THE DEVICE WAS RETURNED TO THE MFR, WHO EVALUATED ITS WALL THICKNESS AND FOUND IT TO BE WITHIN SPEC. THE MFR ALSO FOUND BENT NEEDLES IN THE 3/4 FULL CONTAINER WHICH THEY FELT INDICATED THAT THE USER HAD APPLIED FORCE IN DEPOSITING THE NEEDLE. THE MFR SENT A SAFETY KIT FOR INSERVICING AND SAMPLES OF LARGER CONTAINERS FOR TRIAL. THE FACILITY WAS PLEASED WITH THEIR HANDLING OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPS CONTAINER SHARPS CONTAINER MMK SAGE PRODUCTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other