BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS CONTAINER

    MDR report key: 13729 · Received June 2, 1994

    Report

    Report Number
    MW1002325
    Event Type
    Malfunction
    Date Received
    June 2, 1994
    Report Date
    May 5, 1994
    Manufacturer
    SAGE PRODUCTS, INC.
    Product Code
    MMK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SAGE PRODUCTS,INC. 815 TEK DR, PO BOX 9693, CRYSTAL LAKE, IL 60014-9693. OUR EVALUATION OF THE FULL #8980 CONTAINER REVEALED BENT NEEDLES IN THE CONTAINER. BASED ON OUR EXPERIENCE, BENT NEEDLES ARE AN INDICATOR THAT FORCE WAS APPLIED. THE WALL THICKNESS WAS MEASURED AT THE PUNCTURE SITE AND FOUND TO BE WITHIN SPEC. OUR CONCLUSION FOR THESE PUNCTURES IS THE CONTAINERS INVOLVED ENCOUNTERED SOME TYPE OF EXCESSIVE FORCE. WITH THESE FINDINGS WE DETERMINED THAT THESE EVENTS ARE NOT ATTRIBUTABLE TO THE MEDICAL DEVICE (SHARPS DISPOSAL CONTAINERS) BUT ARE DUE TO USER ERROR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other