BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS CONTAINER

    MDR report key: 18898338 · Received March 12, 2024

    Report

    Report Number
    MW5152803
    Event Type
    Malfunction
    Date Received
    March 12, 2024
    Date of Event
    January 1, 2024
    Report Date
    March 10, 2024
    Manufacturer
    POST MEDICAL, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE VISITED SOME MEDICAL FACILITIES THAT USE POST MEDICAL SHARPS CONTAINERS, MODEL 2201-LPBW. AS FAR AS I CAN TELL FROM THE FDA WEBSITE THE CONTAINERS MAY HAVE A 510(K) NUMBER OF K925816. THE CONTAINERS THEMSELVES DO NOT HAVE A K NUMBER. THE ISSUE OBSERVED IS THAT THE CONTAINERS HAVE TWO FILL LINES. ONE ON THE FRONT ON A STICKER THAT HAS THE BIOHAZARDOUS SYMBOL AND COMPANY INFORMATION. THE SECOND LINE IS ON THE BACK OF THE CONTAINER AND HIGHER THAN THE FRONT LINE. THE LINE IS NOT VERY VISIBLE AS IT DOES NOT STAND OUT AND IS PART OF THE MOLDING OF THE CONTAINER. WHEN THE CONTAINERS ARE FILLED TO THE BACK LINE THE FRONT LINE SHOWS THAT THE CONTAINER IS TOO FULL. FROM MY OBSERVATIONS THE BACK LINE MAY BE FOR USE WITH SECURITY WALL MOUNT PART NUMBER 88-SFP OR SIMILAR WALL MOUNT. THE CONCERN IS THAT THE HIGHER LINE IS PERMANENT WHILE THE LOWER LINE IS NOT. THE STICKER CAN BE REMOVED OR CUT TO MAKE THE HIGHER LINE THE FILL LINE. ASSUMING THAT THE HIGHER LINE IS THE FILL LINE ONLY FOR WHEN USING THE WALL MOUNT, THEN WHAT IS IT TO STOP A USER FROM USING THAT HIGHER LINE WHEN NOT USING THE WALL MOUNT. THIS MAY BE CONFUSING TO USERS. WHEN USING THE WALL MOUNT IT CAN BE ASSURED THAT THE HIGHER LINE IS USED, BUT WHEN NOT USING THE WALL MOUNT IT CANNOT BE ASSURED THAT THE LOWER FILL LINE WILL BE USED. I HAVE INCLUDED A PICTURE OF A CONTAINER BEING SHOWN AS OVERFILLED ACCORDING TO THE FRONT STICKER BUT IT WOULD NOT BE OVERFILLED ACCORDING TO THE MOLDED FILL LINE ON THE OTHER SIDE OF THE CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266780 SHARPS CONTAINER NEEDLE, HYPODERMIC, SINGLE LUMEN FMI POST MEDICAL, INC. 2201--LPBW 0081517

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown