BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOSEAL NEONATAL NASAL PRONG SEAL

    MDR report key: 21423581 · Received February 20, 2025

    Report

    Report Number
    MW5166558
    Event Type
    Injury
    Date Received
    February 20, 2025
    Date of Event
    January 24, 2018
    Report Date
    February 16, 2025
    Manufacturer
    NEOTECH PRODUCTS, LLC
    Product Code
    BXJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TERM, FEMALE INFANT WAS HOSPITALIZED FOR PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN. SHE INGESTED FOAM, NEONATAL NASAL CANNULA SEAL AT THE NEGLIGENCE OF HOSPITAL NEONATAL INTENSIVE CARE UNIT STAFF. INFANT HAD PROLONGED HOSPITAL STAY AND HAD TO BE SEDATED MULTIPLE TIME FOR STRUGGLING TO BREATH. OXYGEN LEVELS CONTINUED TO DECLINE. SEDATION WAS NEEDED TO CALM INFANT BECAUSE OF PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN DIAGNOSIS AND RISK OF FURTHER PULMONARY ISSUES WHEN CRYING/BEING UPSET. TWO WEEKS AFTER ADMISSION, PATIENT WAS RELEASED AND SENT HOME. MOTHER DISCOVERED CANNULA SEAL IN A BOWEL MOVEMENT THREE DAYS AFTER BEING SENT HOME. RISKS AND HARM OF INFANT INGESTING THIS SEAL WERE INFINITE. THE HARM DONE AND RISK OF SUFFOCATION WERE INFINITE. INCIDENT OCCURRED AT (B)(6) HOSPITAL NEONATAL INTENSIVE CARE UNIT IN (B)(6) THE WEEK OF (B)(6) 2018. WHATEVER PRODUCTS WERE USED FOR CPAP DEVICES IN THE NEONATAL INTENSIVE CARE UNIT ARE A RISK FOR INGESTION AND DEATH BY SUFFOCATION OF INFANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402989 NEOSEAL NEONATAL NASAL PRONG SEAL CLIP, NOSE BXJ NEOTECH PRODUCTS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Female Other| H