BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ISIS SUBCLOTTIC ENDOTRACHEAL TUBE, 6.0

    MDR report key: 2910048 · Received November 9, 2012

    Report

    Report Number
    3003898360-2012-00520
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    October 6, 2012
    Report Date
    October 29, 2012
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER REPORTED IN THE COMPLAINT (M2122T609) IS NOT A VALID LOT NUMBER. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS THE CUFF LEAKED DURING USE. THE PT CONDITION IS LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON ISIS SUBCLOTTIC ENDOTRACHEAL TUBE, 6.0 ET TUBE BTR TELEFLEX M2122T609

    Patients

    Seq Age Sex Outcome Treatment
    1