BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGT ORAL CUFFED ENDOTRACHEAL TUBE

    MDR report key: 249798 · Received November 10, 1999

    Report

    Report Number
    8040412-1999-00093
    Event Type
    Malfunction
    Date Received
    November 10, 1999
    Date of Event
    October 27, 1999
    Report Date
    November 9, 1999
    Manufacturer
    RUSCH MALAYSIA
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT IS ALLEGED THAT TWO PIECES OF THE SAME LOT EXHIBITED LEAKAGE OF THE CUFF. THE PATIENTS WERE SUBSEQUENTLY RE-INTUBATED, AND NO FURTHER CONSEQUENCES ARE REPORTED. CUSTOMER ALSO INDICATES THAT THE TUBES WERE TOO RIGID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGT ORAL CUFFED ENDOTRACHEAL TUBE ENDOTRACHEAL TUBE-CUFFED BTR RUSCH MALAYSIA NA 99120

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN