BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ENDOTRACHEAL TUBE, HVT, 7.5

    MDR report key: 3063609 · Received April 12, 2013

    Report

    Report Number
    3003898360-2013-00142
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 17, 2013
    Report Date
    March 27, 2013
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 RETURNED FOR EVALUATION THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: COMPLAINT ALLEGES THAT THE ET TUBE ADAPTER POPPED OFF AND THE ET TUBE MIGRATED DOWN THE PT'S NARE. THE THERAPIST USED MAGILL FORCEPS TO PULL THE TUBE OUT AND RECONNECT THE ADAPTER. THE CONDITION OF THE PT IS LISTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157925 HUDSON ENDOTRACHEAL TUBE, HVT, 7.5 ET TUBE BTR TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1