BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EB ROBERTSHAW LEFT 39F

    MDR report key: 4066573 · Received August 8, 2014

    Report

    Report Number
    8040412-2014-00185
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 23, 2014
    Manufacturer
    TELEFLEX MEDICAL EUROPE LTD.
    Product Code
    BTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE CONNECTION TO THE BRONCHIAL LUMEN BECAME DISLOCATED. AS A RESULT, IT WAS NOT POSSIBLE TO VENTILATE THE PATIENT USING THE CONTROLLED VENTILATION. A NEW CATHETER WAS OPENED AND THE CONNECTION WAS CHANGED. THERE WERE NO CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466912 RUSCH EB ROBERTSHAW LEFT 39F ENDOBRONCHIAL TUBE BTS TELEFLEX MEDICAL EUROPE LTD. 14BT21

    Patients

    Seq Age Sex Outcome Treatment
    1