BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH LASERTUBUS ENDOTRACHEAL TUBE 6MM

    MDR report key: 4240242 · Received October 29, 2014

    Report

    Report Number
    9610520-2014-00017
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 30, 2014
    Manufacturer
    TELEFLEX
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED, HOWEVER, THE INVESTIGATION WAS NOT COMPLETE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE LASER TUBE KINKED/BROKE DURING THE INTUBATION, HYPERVENTILATION OCCURRED, SATURATION WENT DOWN, AND THE PATIENT WAS REINTUBATED WITH A STANDARD ET TUBE." THE CURRENT CONDITION OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691298 RUSCH LASERTUBUS ENDOTRACHEAL TUBE 6MM LASERTUBUS ET TUBE BTR TELEFLEX 14161

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention