BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTECH NEOSEAL

    MDR report key: 3733015 · Received March 29, 2014

    Report

    Report Number
    2025917-2014-00006
    Event Type
    Injury
    Date Received
    March 29, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 28, 2014
    Manufacturer
    NEOTECH PRODUCTS, INC.
    Product Code
    CAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED IN SECTIONS:: THE COMPLAINANT WAS UNABLE TO OBTAIN THIS INFORMATION. THE DEVICE INVOLVED IN THE COMPLAINT WAS NOT RETURNED TO THE MANUFACTURER, AS IT WAS DISPOSED OF BY THE FACILITY. THE COMPLAINANT ADMITTED THAT THE DEVICE WAS BEING USED OFF-LABEL, AS IT WAS BEING USED ON THE NEOTECH RAM CANNULA. DIRECTIONS FOR USE FOR THE NEOSEAL STATE THAT IT IS NOT TO BE USED WITH THE RAM CANNULA. FURTHERMORE, THE DIRECTIONS FOR USE FOR THE RAM CANNULA STATE THAT THERE SHOULD BE A "SMALL GAP BETWEEN THE SEPTUM AND THE BASE OF THE PRONGS." MANUFACTURER TESTING WAS PERFORMED ON RETAINED SAMPLES FROM THE SAME LOT NUMBER . THE COMPLAINT WAS CONFIRMED AND IT WAS DETERMINED THAT THE DETACHMENT OF THE NEOSEAL WAS LIKELY DUE TO THE MOISTURE FROM THE PATIENT'S MOUTH, AS WELL AS SLIGHT MANIPULATION OR MOVEMENT BY THE PATIENT AS WELL, HOWEVER THE DEVICE PERFORMED AS INTENDED. THE DIRECTIONS FOR USE STATE THAT THE NEOSEAL SHOULD NOT BE SOAKED. THE OFF-LABEL USE OF THE DEVICE WAS LIKELY A CONTRIBUTING FACTOR. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE NASAL PRONG SEAL WAS FOUND IN THE PATIENT'S MOUTH. THE COMPLAINANT ADMITTED THAT THE USER FACILITY STAFF WERE NOT FOLLOWING THE DIRECTIONS FOR USE AT THE TIME THE EVENT OCCURRED. THE STAFF NOTICED THAT THE CANNULA HAD SLID DOWN NEAR THE PATIENT'S MOUTH AND FELT THAT "THE MOISTURE FROM THE MOUTH MUST HAVE LOOSENED THE NEOSEAL." THE SEAL WAS REMOVED FROM THE PATIENT'S MOUTH AND THE PATIENT SUFFERED NO INJURY. THE FACILITY STATED THAT THERE HAVE BEEN NO OTHER ISSUES WITH THE NEOSEAL LOT INVOLVED, BUT STATED THAT THEY WILL NOTIFY THE MANUFACTURER SHOULD ANY SIMILAR EVENTS OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187117 NEOTECH NEOSEAL NASAL PRONG CPAP SEAL CAT NEOTECH PRODUCTS, INC. N421 23796

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention NEOTECH RAM CANNULA WAS BEING USED WITH THE| NEOSEAL