BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTECH PRODUCTS

    MDR report key: 17575314 · Received August 18, 2023

    Report

    Report Number
    2025917-2023-00002
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    July 12, 2023
    Report Date
    August 18, 2023
    Manufacturer
    NEOTECH PRODUCTS LLC
    Product Code
    BXJ
    UDI-DI
    10812594012164
    PMA / PMN Number
    N/AN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR RESPONSE TO THE REPORT SENT TO US BY FDA AND FILED BY (B)(6) HOSPITAL - (B)(6). (REPORT NUMBER: MW5120017). THE ACTUAL DEVICE WAS NOT RETURNED, AND NO TEST WAS POSSIBLE ON THE ACTUAL DEVICE. HOWEVER, RETAINED SAMPLES OF THE SAME LOT NUMBER WERE RE-INSPECTED AND NO ABNORMALITY WAS FOUND. THE PRESENCE OF ADHESIVE WAS VERIFIED AND THE CONDITION OF ADHESIVE AND ITS ABILITY OF STICKING TO DEVICE WAS VERIFIED. IN ADDITION, THE PRODUCT'S DEVICE HISTORY RECORDS (DHR) OF THE CURRENT INVENTORY WERE REVIEWED AND NO NONCONFORMITY WAS FOUND. SAMPLES OF FINISHED GOODS WERE PULLED OUT FROM RETAINED SAMPLES OF THE CURRENT LOT NUMBER FOR RE-INSPECTION AND NO ABNORMALITY WAS FOUND. THE PRESENCE OF ADHESIVE WAS VERIFIED AND THE CONDITION OF ADHESIVE AND ITS ABILITY OF STICKING TO THE DEVICE WAS VERIFIED AS WELL. WITHIN THE "INSTRUCTION FOR USE" OF THE DEVICE, NEOTECH CLEARLY MENTIONED THE FOLLOWINGS: · STEP 3 INSERT PRONGS PER HOSPITAL PROTOCOL. DOCUMENT PLACEMENT OF THE NEOSEAL IN THE PATIENT'S MEDICAL RECORD. · NOTE: TO MINIMIZE RISK OF ASPIRATION/INGESTION, ENSURE THE NASAL CANNULA PRONGS AND/OR NEOSEAL DO NOT ENTER THE INFANT'S MOUTH. · STEP 4 REPLACE NEOSEAL DAILY OR PER HOSPITAL PROTOCOL, WHICHEVER IS SOONER. · NOTE: REPLACE IMMEDIATELY IF SOILED OR WET. · STEP 5 DOCUMENT REMOVAL AND/OR REPLACEMENT IN THE PATIENT'S MEDICAL RECORD. · CAUTIONS & WARNINGS. · FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. · CHOKING HAZARD. NEOSEAL SHOULD ONLY BE USED WHILE THE PATIENT IS UNDER THE CONTINUOUS, DIRECT SUPERVISION OF TRAINED HEALTHCARE PROFESSIONALS. · RISK OF INGESTION OR ASPIRATION. WHEN IN USE, ENSURE THE NASAL CANNULA PRONGS AND/OR NEOSEAL DO NOT ENTER THE INFANT'S MOUTH. · REPLACE IMMEDIATELY IF SOILED OR WET. IT SEEMS THE INSTRUCTIONS FOR USE WAS NOT FOLLOWED PROPERLY. NEOTECH HAS DECIDED TO IMPROVE THE EFFECTIVENESS OF CAUTIONS & WARNINGS BY PRINTING THE CHOCKING HAZARD ON THE LINERS OF ACTUAL DEVICES. BASED ON THE COMPLAINT RATIO, THE INCIDENT APPEARS TO BE ISOLATED AND OF VERY RARE OCCURRENCE. THIS COMPLAINT WILL BE MONITORED FOR TRENDING PURPOSES AND IS ADDED TO THE RELATED LOGS AND CHARTS.

    Description of Event or Problem · 0

    A 42 WEEK INFANT WHO WAS ADMITTED TO NICU FOLLOWING BIRTH NEEDING RESPIRATORY SUPPORT VIA NASAL CANNULA. NEOTECH FOAM BARRIER IN PLACE. INFANT FOUND TO BE DESATURATING AND CHOKING ON FOAM BARRIER. ONCE RN REMOVED FOAM BARRIER INFANT RECOVERED IMMEDIATELY. FOAM BARRIERS REMOVED FROM UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166851 NEOTECH PRODUCTS NEOSEAL BXJ NEOTECH PRODUCTS LLC N420 2022-0101 10812594012164

    Patients

    Seq Age Sex Outcome Treatment
    1 42 WK Unknown Life Threatening