BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWCARE GOOSENECK

    MDR report key: 12835446 · Received November 17, 2021

    Report

    Report Number
    MW5105417
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    November 2, 2021
    Report Date
    November 16, 2021
    Manufacturer
    THERMEDIA CORPORATION
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT FOR TRACHEOSTOMY; AFTER PROCEDURE WAS COMPLETE UNABLE TO DISCONNECT GOOSE NECK FROM HUB OF THE TRACH. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723824 FLOWCARE GOOSENECK CONNECTOR, AIRWAY (EXTENSION) BZA THERMEDIA CORPORATION 2200 2871

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male