BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMT BRIDLE NASAL TUBE RETAINING SYSTEM

    MDR report key: 2976447 · Received February 13, 2013

    Report

    Report Number
    1526012-2013-00002
    Event Type
    Other
    Date Received
    February 13, 2013
    Date of Event
    September 24, 2012
    Report Date
    December 31, 2012
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    PMA / PMN Number
    K030784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON A REVIEW OF THE INFO, THERE WAS NO DEATH. THERE WAS NO SERIOUS INJURY, AS DEFINED BY THE FDA. THIS WAS NOT LIFE-THREATENING, NOR DID THIS RESULT IN PERMANENT IMPAIRMENT. HOWEVER, DUE TO THE IMPROPER USE OF THE DEVICE, INTERVENTION WAS REQUIRED TO REMOVE THE STYLET FROM THE PT'S NARES. THE DEVICE WAS NOT RETURNED FOR INSPECTION, SO AN ANALYSIS OF THE DEVICE COULD NOT BE PERFORMED. THE CONDITION CAUSED BY THE DEVICE WAS THE RESULT OF NOT FOLLOWING THE DIRECTIONS FOR USE. THE FOLLOWING IS AN EXCERPT FROM THE BRIDLE DIRECTIONS FOR USE: IT MAY BE NECESSARY TO ADVANCE OR MANIPULATE THE PROBE TO ACHIEVE MAGNET CONTACT; REMOVE STYLET AFTER MAGNET CONNECTION; IF NECESSARY, GENTLY TWIST THE PROBES FROM SIDE TO SIDE AND/OR UP AND DOWN TO ENCOURAGE CONTACT BETWEEN THE MAGNETS. IF NO CONTACT HAS OCCURRED, THEN ADVANCE BOTH THE WHITE CATHETER AND THE BLUE PROBE. IMPORTANT: ONCE CONTACT HAS OCCURRED, REMOVE THE ORANGE STYLET COMPLETELY FROM THE WHITE CATHETER AND DISPOSE. BASED ON A REVIEW OF THE INFO, THE DEVICE WAS USED IMPROPERLY AND DANGEROUSLY, AND THE DIRECTIONS FOR USE WERE NOT FOLLOWED. THE DEVICE DID NOT MALFUNCTION. THE EXCERPT FROM THE DIRECTIONS OF USE ABOVE SHOWS THAT THE INSTRUCTIONS CALL FOR THE REMOVAL OF THE STYLET AFTER MAGNET CONNECTION. A SECOND (HIGHLIGHTED) INSTRUCTION IS INCLUDED TO CALL THE IMPORTANCE IN REMOVING THE ORANGE STYLET AND DISPOSING THE COMPONENT. THE USER OF THE DEVICE DID NOT FOLLOW THE DIRECTIONS FOR USE AND PULLED THE STYLET AND ORANGE HANDLE THROUGH THE PT'S NOSE. IN ADDITION, A DHR REVIEW SHOWED NO ANOMALIES. NOR WAS THE AMT DEVICE RETURNED TO AMT FOR ANALYSIS. AMT WILL PROVIDE ADD'L INFO TO THE FDA WHEN/IF THE DEVICE IS ABLE TO BE RETRIEVED AND ANALYSIS OF THE DEVICE CHANGES THE CONCLUSION OF THIS REPORT.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64095 AMT BRIDLE NASAL TUBE RETAINING SYSTEM TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT APPLIED MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other