BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOTECH PRODUCTS

    MDR report key: 17830541 · Received September 27, 2023

    Report

    Report Number
    2025917-2023-00003
    Event Type
    Injury
    Date Received
    September 27, 2023
    Date of Event
    April 5, 2023
    Report Date
    September 27, 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
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS OUR RESPONSE TO THE REPORT SENT TO US BY FDA AND FILED BY GREENWICH HOSPITAL - CT. (UF REPORT# (B)(4) THE ACTUAL DEVICE WAS NOT RETURNED, AND NO TEST WAS POSSIBLE ON THE ACTUAL DEVICE. HOWEVER, RETAINED SAMPLES OF THE CURRENT 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 OTHER LOT NUMBERS 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

    AN INFANT IN THE NICU WAS REPORTED BY THE PARENT TO HAVE COUGHED UP A PIECE OF NEOSEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2261663 NEOTECH PRODUCTS NEOSEAL BXJ NEOTECH PRODUCTS LLC N420 UNKNOWN 10812594012164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other