BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3123984 · Received May 15, 2013

    Report

    Report Number
    2134070-2013-00107
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 25, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K043592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION SHOWED THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION WITHOUT THE MATCHING OBTURATOR. UPON EVAL, IT WAS FOUND THAT THE RUBBER GASKET WAS MISSING FROM THE SLEEVE. A PRESSURE TEST WAS PERFORMED AND THE DEVICE SHOWED SIGNS OF LEAKING WHEN AN OBTURATOR WAS INSERTED INTO THE SLEEVE. THE DEVICE PASSED A PIN GAP TEST. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THORACIC CASE THE DEVICE FAILED DURING SURGERY. IT DID NOT SEAL PROPERLY AND WAS LEAKING. INSUFFLATION WAS LOST AND COULD NOT BE MAINTAINED. THE DEVICE WAS REPLACED WITH ANOTHER PORT THAT WORKED "JUST FINE." THERE WAS NO PT INJURY OR CONSEQUENCES. IT WAS BELIEVED THAT THE SEAL IN THE TOP PORTION OF THE PORT MAY HAVE BEEN MISSING. ADD'L INFO REGARDING THE PT WAS REQUESTED, BUT NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214852 NA NLM STERILMED, INC. AUTNB12STF 1575047

    Patients

    Seq Age Sex Outcome Treatment
    1