BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 QUART SHARPS CONTAINER

    MDR report key: 2192715 · Received July 26, 2011

    Report

    Report Number
    1651383-2011-00002
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    SHARPS COMPLIANCE, INC.
    Product Code
    FMI
    PMA / PMN Number
    K945275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ON THE CONTAINER WALL THICKNESS DETERMINED THAT THE CONTAINER WAS MANUFACTURED WITHIN THE ESTABLISHED REQUIREMENTS OF 0.045 INCHES MINIMUM. VISUAL EXAMINATION OF THE CONTAINER HAS DETERMINED THE MOST LIKELY CAUSE OF THE NEEDLE PROTRUDING THROUGH THE 1 QUART SHARPS CONTAINER WAS THROUGH APPLICATION OF EXCESSIVE FORCE ON THE NEEDLE DURING INSERTION (POSSIBLY DUE TO OVERFILLING). ALL SHARPS CONTAINERS ARE PUNCTURE RESISTANT, NOT PUNCTURE PROOF. PRODUCT LABELING ON THE CONTAINER STATES "CONTAINERS ARE PUNCTURE RESISTANT, NOT NECESSARILY PUNCTURE PROOF", AND INSTRUCTIONS FOR USE STATES "DO NOT OVERFILL (FILL LINE IS NOTED ON CONTAINER LABEL.) LID MUST FIT DOWN TIGHTLY."

    Description of Event or Problem · 1

    IT WAS REPORTED TO SHARPS COMPLIANCE INC. ON (B)(6) 2011 THAT A CUSTOMER WAS STUCK WITH A NEEDLE PROTRUDING FROM A 1 QUART SHARPS CONTAINER (MODEL NUMBER 10100) ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1 QUART SHARPS CONTAINER SHARPS CONTAINER FMI SHARPS COMPLIANCE, INC. 10100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR