BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OHIO ENDOTRACHEAL TUBE

    MDR report key: 16697 · Received October 10, 1994

    Report

    Report Number
    MW1003640
    Event Type
    Malfunction
    Date Received
    October 10, 1994
    Date of Event
    September 16, 1994
    Report Date
    September 28, 1994
    Manufacturer
    SHERIDAN CATHETER CORP.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ETT IN PT NOTED TO BE AT 21 INCH MARKING WHEN IT WAS SUPPOSED TO BE AT 23 INCHES. PT HAD BEEN RESTLESS AND PULLING AT TUBE. ANESTHESIA CALLED TO ADVANCE ETT AND WAS UNABLE TO DEFLATE CUFF. PT HAD TO BE EXTUBATED AND REINTUBATED WITH NEW ETT. OLD ONE FOUND TO BE DEFECTIVE DUE TO INABILITY TO DEFLATE CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHIO ENDOTRACHEAL TUBE E.T. TUBE NASAL ORAL BTR SHERIDAN CATHETER CORP. 021044

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR