BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EB CARLENS W/CARINA HOOK

    MDR report key: 4142691 · Received September 24, 2014

    Report

    Report Number
    8040412-2014-00219
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 2, 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. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE BLUE BRONCHIAL CONNECTOR SPONTANEOUSLY SEPARATED, THIS RESULTED IN A LEAK IN WHICH THE ORIGIN WAS HARD TO DETECT AND TRANSLATED IN BAD VENTILATION TO THE PATIENT. IT IS REPORTED THAT THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593769 RUSCH EB CARLENS W/CARINA HOOK ENDOBRONCHIAL TUBE BTS TELEFLEX MEDICAL EUROPE LTD. 14CT11

    Patients

    Seq Age Sex Outcome Treatment
    1