BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH CARLENS EB TUBE WITH CARINA HOOK

    MDR report key: 3190579 · Received June 21, 2013

    Report

    Report Number
    8040412-2013-00109
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 4, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOTED RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING PULMONARY EXCLUSION IT IS BROKEN THE CONNECTOR OF THE BREATHING CIRCUIT WITH THE TUBE OF THE CARLENS ENDOBRONCHIAL TUBE. THE PATIENT'S CONDITION REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282576 RUSCH CARLENS EB TUBE WITH CARINA HOOK ENDOBRONCHIAL TUBE CBI TELEFLEX MEDICAL 12HE32

    Patients

    Seq Age Sex Outcome Treatment
    1