BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD

    MDR report key: 7064125 · Received November 28, 2017

    Report

    Report Number
    8030673-2017-00389
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    November 21, 2017
    Report Date
    December 11, 2017
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    BZA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE AVAILABLE. HOWEVER BASED ON THE CUSTOMER STATING THE PRODUCT WAS IN USE FOR 1 YEAR AND 5 DAYS, OUR IFU STATES THIS PRODUCT SHOULD NOT BE USED LONGER THAN 30 DAYS AS THE PRODUCT CAN BECOME DEFORMED OR DISCOLORED. THE CUSTOMER HAS BEEN PROVIDED THE IFU AND INSTRUCTED ON THE PROPER USE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    INITIAL EMDR SUBMISSION: SAMPLE IS AVAILABLE, UPS SHIPPING LABELS PROVIDED TO CUSTOMER TO HAVE THE SAMPLE RETURNED. CURRENTLY AWAITING FOR THE SAMPLE. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP SUBMISSION WILL BE FILED.

    Description of Event or Problem · 1

    WE HAVE BEGUN TO INVESTIGATE ALL OUR PATIENTS WITH THIS ADAPTER AND O2 WITH SLEEP EQUIPMENT TO VISUALLY INSPECT ALL EQUIPMENT. WE HAVE SINCE FOUND 2 MORE PATIENTS AND INCIDENCE OF MELTED ADAPTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843385 CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD CONNECTOR, AIRWAY (EXTENSION) BZA VYAIRE MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention