BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EZ-BLOCKER ENDOBRONCHIAL BLOCKER

    MDR report key: 3020714 · Received March 18, 2013

    Report

    Report Number
    1044475-2013-00036
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 1, 2013
    Manufacturer
    TELEFLEX
    Product Code
    CBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE COMPLAINT ALLEGES THAT ONE OF THE TWO CUFF PILOT WAS CUT INTO THE POUCH. THE TWO END TIPS WERE VERY RELATIVELY CLOSE SO DURING USE THEY WENT INTO THE SAME BRONCHUS. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111944 RUSCH EZ-BLOCKER ENDOBRONCHIAL BLOCKER ENDOBRONCHIAL BLOCKER CBI TELEFLEX 550711

    Patients

    Seq Age Sex Outcome Treatment
    1