BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3001988 · Received March 11, 2013

    Report

    Report Number
    2134070-2013-00057
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Report Date
    February 27, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K012578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. UPON EVALUATION IT WAS FOUND THAT THE STOPCOCK LEVER WAS LOOSE AND DID NOT HAVE SUFFICIENT FRICTION TO PREVENT UNINTENDED MOVEMENT. THE DEVICE THEN WAS TESTED FOR LEAKING. THE DEVICE SHOWED SIGNS OF LEAKING WHEN THE OBTURATOR WAS INSERTED INTO THE SLEEVE, BUT NOT WHEN THE SLEEVE WAS TESTED WITHOUT THE OBTURATOR. AS NO PACKAGING WAS RETURNED WITH THE DEVICE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER WITH NO INFORMATION. ADDITIONAL INFORMATION WAS REQUESTED, AND IT WAS REPORTED THAT THE REGULATOR LEVER FOR THE GAS WAS LOOSE. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102043 NA NLM STERILMED, INC. AUT177092

    Patients

    Seq Age Sex Outcome Treatment
    1