BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH CARLENS ENDOBRONCHIAL TUBE, 39F

    MDR report key: 2833865 · Received November 5, 2012

    Report

    Report Number
    8040412-2012-00179
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 26, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE TIP OF THE TUBE HAS A DEFECT AND LEAKED DURING VENTILATION. THE EB TUBE WAS REMOVED AND CHANGED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH CARLENS ENDOBRONCHIAL TUBE, 39F ENDOBRONCHIAL TUBE BTS TELEFLEX MEDICAL 12CE10

    Patients

    Seq Age Sex Outcome Treatment
    1