BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2922048 · Received January 15, 2013

    Report

    Report Number
    2134070-2013-00010
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 2, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K111002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND TWO CRACKS ALONG THE INSIDE OF THE CANNULA. THE DUCKBILL SEAL WAS EXAMINED AND FOUND TO BE ACCEPTABLY CLOSED AT THE SLIT. THE SLEEVE WAS THEN FUNCTIONALLY TESTED FOR LEAKING. THE DEVICE PASSED A LEAK TEST WHEN THE SLEEVE WAS TESTED BY ITSELF, BUT SHOWED EVIDENCE OF LEAKING DURING INSERTION OF A TEST OBTURATOR THROUGH THE DEVICE, AND OF MINOR LEAKING WHEN THE TEST OBTURATOR WAS FULLY INSERTED INTO THE DEVICE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED. AS EACH DEVICE IS VISUALLY AND FUNCTIONALLY TESTED PRIOR TO BEING RELEASED, NO CONCLUSION COULD BE REACHED REGARDING WHAT MIGHT HAVE CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SEAL FAILED ON TWO DEVICES. THE DEVICES WERE REPLACED. THERE WERE NO KNOWN INJURIES OR CONSEQUENCES TO THE PT. THIS REPORT IS FOR THE SECOND DEVICE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS AVAILABLE. SEE MFR REPORT #2134070-2013-00009 REGARDING THE FIRST DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22561 NA NLM STERILMED, INC. APPCTS02

    Patients

    Seq Age Sex Outcome Treatment
    1