BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EB CARLENS W/CARINA HOOK

    MDR report key: 4054315 · Received August 15, 2014

    Report

    Report Number
    8040412-2014-00190
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 31, 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

    A REQUEST FOR ADDITIONAL INFO WAS REQUESTED FROM THE USER FACILITY. THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491736 RUSCH EB CARLENS W/CARINA HOOK BTS TELEFLEX MEDICAL EUROPE LTD 14CT11

    Patients

    Seq Age Sex Outcome Treatment
    1