BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ- BLOCKER ENDOBRONCHIAL BLOCKER

    MDR report key: 4345506 · Received December 5, 2014

    Report

    Report Number
    3003637635-2014-00003
    Event Type
    Malfunction
    Date Received
    December 5, 2014
    Date of Event
    November 6, 2014
    Report Date
    December 4, 2014
    Manufacturer
    CONTRACT MEDICAL INTERNATIONAL GMBH
    Product Code
    CBI
    PMA / PMN Number
    K121462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION REQUESTED REGARDING THE PATIENT'S CONDITION. NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT. ALL EZB BALLOON CATHETERS ARE 100% INSPECTED FOR AIR LEAKAGE DURING CMI PRODUCTION. AND ONE OF THE INSPECTION CRITERIA IS 100% GO NO GO TO TEST OF BALLOON DIAMETER. THE BALLOON MUST HAVE A DIAMETER BETWEEN 17 MM AND 29 MM. CMI DID A TESTING WITH ONE SAMPLE EZ-BLOCKER FROM PRODUCTION TO CHECK BALLOON DIAMETER INFLATED UP TO 20ML AS STATED IN COMPLAINT REPORT. THE BALLOON INFLATED UP TO 20ML COULD EASILY PASS THE GO NO GO GAUGE. ESTIMATED DATE OF FOLLOW UP REPORT IS (B)(6) 2015.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THERE MAY HAVE BEEN AN OVER INFLATION ISSUE WITH THE BALLOON. THE DOCTOR REPORTS POSSIBLE LACERATION OF THE MAINSTREAM BRONCHUS. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786195 EZ- BLOCKER ENDOBRONCHIAL BLOCKER ENDOBRONCHIAL BLOCKER CBI CONTRACT MEDICAL INTERNATIONAL GMBH 572137

    Patients

    Seq Age Sex Outcome Treatment
    1