BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOTECH PRODUCTS

    MDR report key: 22522664 · Received July 16, 2025

    Report

    Report Number
    2025917-2025-00001
    Event Type
    Malfunction
    Date Received
    July 16, 2025
    Report Date
    July 11, 2025
    Manufacturer
    NEOTECH PRODUCTS LLC
    Product Code
    BXJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED; THEREFORE, NO EVALUATION COULD BE CONDUCTED ON THE ACTUAL UNIT. RETAINED SAMPLES FROM THE CURRENT INVENTORY OF ALL THREE CATALOG NUMBERS AND THEIR RESPECTIVE DEVICE HISTORY RECORDS (DHRS), WERE REVIEWED, AND NO ISSUES WERE IDENTIFIED. AS THE MANUFACTURER, WE HAVE TAKEN EXTENSIVE STEPS TO MITIGATE THE RISK OF SUCH INCIDENTS. THIS SPECIFIC RISK IS CLEARLY OUTLINED IN OUR DIRECTIONS FOR USE, WHERE WE EMPHASIZE THE NECESSITY OF DIRECT SUPERVISION BY TRAINED HEALTHCARE PROFESSIONALS. THE CAUTION IS ALSO CLEARLY PRINTED ON THE BACK OF THE DEVICE LINER. FURTHERMORE, WE HAVE SPECIFICALLY ADVISED THAT ANY PLACEMENT, REMOVAL, OR REPLACEMENT OF THE DEVICE MUST BE DOCUMENTED IN THE PATIENT'S MEDICAL RECORDS, WHICH IS ESSENTIAL FOR TRACEABILITY AND PATIENT SAFETY. PROPER USE AND DOCUMENTATION BY THE END USER ARE CRITICAL. HAD THE OUTLINED PROCEDURES BEEN FOLLOWED, NOT ONLY WOULD THE PRODUCT DETAILS (E.G., PART AND LOT NUMBERS) HAVE BEEN READILY ACCESSIBLE, BUT IT IS LIKELY THAT THE INCIDENT COULD HAVE BEEN PREVENTED ALTOGETHER. WE KINDLY ASK AND REEMPHASIZE TO OUR CUSTOMERS AND END USERS THE IMPORTANCE OF CAREFULLY REVIEWING AND ADHERING TO ALL PROVIDED INSTRUCTIONS, PARTICULARLY THE CAUTIONS AND WARNINGS. DOING SO ENSURES THE HIGHEST STANDARD OF SAFETY FOR PATIENTS AND SUPPORTS EFFECTIVE INCIDENT MANAGEMENT SHOULD ANY ISSUES ARISE. THIS INCIDENT HAS BEEN LOGGED AND WILL BE MONITORED FOR TRENDING PURPOSES.

    Description of Event or Problem · 0

    TERM INFANT BORN IN THE HOSPITAL AND ADMITTED TO NICU. RECEIVED NON-INVASIVE RESPIRATORY SUPPORT VIA MASK AND NASAL PRONG FROM ON (B)(6) 2025. PATIENT DISCHARGE FROM HOSPITAL ON (B)(6) 2025. MASK AND NASAL PRONG ROTATED PER HOSPITAL POLICY. NEW NEOSEAL APPLIED TO NASAL PRONGS WITH ADHESIVE FACING THE CANNULA DURING EACH CHANGE. PATIENT UNDER CONTINUOUS MONITORING AND SUPERVISION BY TRAINED HEALTHCARE PROFESSIONALS. PARENT CONTACTED HOSPITAL ON (B)(6) 2025 THAT PATIENT PASSED THE NEOSEAL IN A BOWEL MOVEMENT. NEOSEAL COULD HAVE INADVERTENTLY COME OFF THE NASAL PRONG AFTER BECOMING MOIST AND PATIENT COULD HAVE SWALLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150536 NEOTECH PRODUCTS NEOSEAL BXJ NEOTECH PRODUCTS LLC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA Male Other