BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EZ-BLOCKER ENDOBRONCHIAL BLOCKER

    MDR report key: 3190576 · Received June 21, 2013

    Report

    Report Number
    1044475-2013-00090
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 BALLOON LEAKED PRIOR TO PROCEDURE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282575 RUSCH EZ-BLOCKER ENDOBRONCHIAL BLOCKER ATRAUMATIC BRONCHUS BLOCKER CBI TELEFLEX MEDICAL 557372

    Patients

    Seq Age Sex Outcome Treatment
    1