BEUDAMED
    FDA Adverse Event Other Summary report: N

    TUBE, GASTROINTESTINAL

    MDR report key: 3207662 · Received June 24, 2013

    Report

    Report Number
    1526012-2013-00004
    Event Type
    Other
    Date Received
    June 24, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 27, 2013
    Manufacturer
    APPLIED MEDICAL TECHNOLOGY, INC.
    Product Code
    KNT
    PMA / PMN Number
    K030784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INSPECTION, SO AN ANALYSIS OF THE DEVICE COULD NOT BE PERFORMED. ADDITIONALLY, THE EXACT CIRCUMSTANCES SURROUNDING THIS EVENT ARE NOT CLEAR. THE USER STATED: "NASAL BRIDLE EMBEDDED IN INTERIOR SEPTUM. STRING WAS REMOVED AND A TRACK FROM THE STRING WAS NOTED AS WELL." IT IS UNCLEAR FROM THIS DESCRIPTION AS TO WHAT EXACTLY OCCURRED DURING THE EVENT. IT IS STATED THAT THE NASAL BRIDLE WAS EMBEDDED IN THE INTERIOR SEPTUM, BUT THE EXACT COMPONENT OF THE BRIDLE DEVICE THAT WAS EMBEDDED IS NOT GIVEN. IT IS FURTHER STATED THAT A TRACK FROM THE STRING WAS NOTED, WHICH COULD INDICATE THAT EXCESSIVE FORCE WAS USED DURING OR AFTER PLACEMENT OF THE DEVICE. ADDITIONALLY, THE EVENT DESCRIPTION CONTINUES WITH FOLLOWING: "APPROPRIATE CLAMP AND CLIPPED INCHES FROM NOSE ALSO NOTICED AND REVIEWED BY A SUPERVISOR PRIOR TO DISCONNECTION." THE AMT BRIDLE DIRECTIONS FOR USE STATES THE FOLLOWING: "IMPORTANT: USE CAUTION WHEN HANDLING THE AMT BRIDLE CLIP NEAR PT'S MOUTH; CONSIDER COVERING PT'S MOUTH. CLIP SHOULD BE LOCATED CLOSE TO NOSTRIL, APPROX 1CM (1/2") OR ONE "FINGER WIDTH" FROM NOSTRIL. NOTE: THE CLIP SHOULD NOT TOUCH THE NOSTRIL." THE EVENT DESCRIPTION INDICATES THAT THE CLAMP WAS CLIPPED TWO INCHES FROM THE NOSE. THE WOULD INDICATE THAT THE CORRECT PROCEDURE FOR PLACING THE BRIDLE DEVICE WAS NOT FOLLOWED, OR THE CLAMP WAS NOT PROPERLY SECURED AND SLIPPED OVER TIME. BASED ON A REVIEW OF THE INFO, THE DEVICE WAS USED IMPROPERLY, AND THE DIRECTIONS FOR USE WERE NOT FOLLOWED. THE DEVICE DID NOT MALFUNCTION. IN ADDITION, A DHR REVIEW SHOWED NO ANOMALIES. NOR WAS THE DEVICE RETURNED TO AMT FOR ANALYSIS. AMT MADE SEVERAL ATTEMPT TO RETRIEVE THE DEVICE AND ADD'L INFO REGARDING THIS EVENT WITH NO SUCCESS. AMT WILL PROVIDE ADD'L INFO TO THE FDA 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

    EVENT DESC: NOTED NASAL BRIDLE EMBEDDED IN INTERIOR SEPTUM. STRING WAS REMOVED AND A TRACK FROM THE STRING WAS NOTED AS WELL. APPROPRIATE CLAMP AND CLIPPED TWO INCHES FROM NOSE ALSO NOTED AND REVIEWED BY A SUPERVISOR PRIOR TO DISCONNECTION. WILL MONITOR FOR FURTHER INCIDENCES AND WILL FOLLOW UP WITH MFG. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286523 TUBE, GASTROINTESTINAL KNT APPLIED MEDICAL TECHNOLOGY, INC. 13023531

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other