BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBAR®

    MDR report key: 18083599 · Received November 7, 2023

    Report

    Report Number
    18083599
    Event Type
    Malfunction
    Date Received
    November 7, 2023
    Date of Event
    September 12, 2023
    Report Date
    September 19, 2023
    Manufacturer
    NEOTECH PRODUCTS LLC
    Product Code
    CBH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NEOBAR WAS FOUND BY THIS REGISTERED NURSE (RN) TO BE PEELING OFF OF THE PATIENT'S FACE. RESOURCE RN, CHARGE RN AND NEONATE NURSE PRACTITIONER (NNP) CALLED TO BEDSIDE. NEOBAR WAS REPLACED BY REGISTERED RESPIRATORY THERAPIST (RRT) AND NNP FOR THE SECOND TIME WITHIN LESS THAN 4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338514 NEOBAR® DEVICE, FIXATION, TRACHEAL TUBE CBH NEOTECH PRODUCTS LLC ULTRA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA Female