BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ENDOTRACHEAL TUBE, HVT, 7.5, NOVA PLUS

    MDR report key: 2833491 · Received October 30, 2012

    Report

    Report Number
    3003898360-2012-00503
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    TELEFLEX
    Product Code
    CBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNK. THE SAMPLE WAS NOT AVAILABLE FOR EVAL, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. MFR WILL CONTINUE TO MONITOR AND TREND RELATED COMPLAINTS.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS "THE NUMBERS ARE RUBBING OFF THE TUBE". NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON ENDOTRACHEAL TUBE, HVT, 7.5, NOVA PLUS ET TUBE CBI TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1