BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHERIDAN 3.5 ETT

    MDR report key: 379072 · Received February 21, 2002

    Report

    Report Number
    MW1024168
    Event Type
    Malfunction
    Date Received
    February 21, 2002
    Date of Event
    January 27, 2002
    Report Date
    February 21, 2002
    Manufacturer
    NA
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 3.5 ETT WAS IN PLACE AND THE PATIENT WAS BEING RESUSCITATED WITH PPV AND CHEST COMPRESSIONS. DURING THIS TIME, MEDICATION WAS ALSO BEING GIVEN DOWN THE ETT. THE ETT BECAME DISCONNECTED BUT THE TUBE ITSELF AND THE CONNECTOR WOULD NOT STAY CONNECTED. THE PATIENT NEEDED TO BE REINTUBATED WITH ANOTHER TUBE. AFTER THE PATIENT WAS IN SPECIAL CARE AND THEY RETAPED THE ETT IT BECAME DISCONNECTED 3 MORE TIMES. THEY WERE FINALLY ABLE TO RECONNECT AND KEEP CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHERIDAN 3.5 ETT TRACHEAL TUBE BTR NA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other