BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON SHERIDAN/CF ENDOTRACHEAL TUBE, 8.5MM

    MDR report key: 1963622 · Received December 21, 2010

    Report

    Report Number
    3003898360-2010-00524
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    October 21, 2010
    Report Date
    December 8, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE DOCTOR FELT RESISTANCE WHEN HE INFLATED THE CUFF OF THE ET TUBE BEFORE USE. THE DOCTOR INTUBATED THE PT AND STATES WHEN EXTUBATING THE PT, THE CUFF FELT STRANGE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON SHERIDAN/CF ENDOTRACHEAL TUBE, 8.5MM ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK