BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-BLOCKER KIT

    MDR report key: 16694462 · Received April 6, 2023

    Report

    Report Number
    3006425876-2023-00354
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    March 10, 2023
    Report Date
    March 10, 2023
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CBI
    UDI-DI
    10801902142372
    PMA / PMN Number
    K121462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    REPORTED ISSUE: DURING A VATS PROCEDURE WITH A 14-YEAR-OLD, 151CM, 38KG, MALE PATIENT THE SUCTION CATHETER WAS BEING USED CONTINUOUSLY. CASE STARTED WITH APPROPRIATE POSITIONING OF EZ BLOCKER UNDER VISION AND ISOLATION OF RIGHT LUNG WITH 6 CC AIR - FOLLOWED BY DEFLATING THE LUNG. PERI PROCEDURE, RIGHT LUNG STARTED VENTILATING PARTIALLY AND HENCE 2 CC AIR WAS ADDED IN THE CUFF. AFTER AN HOUR, THE LUNG STARTED GETTING VENTILATION AGAIN AND GOT INFLATED SLOWLY. THE ANESTHETIST VERIFIED THE CUFF POSITION AND ITS INFLATION BY FOB. ALTHOUGH EZB APPEARED FINE BUT LUNG ISOLATION WAS NOT POSSIBLE.

    Description of Event or Problem · 0

    REPORTED ISSUE: DURING A VATS PROCEDURE WITH A 14-YEAR-OLD, 151CM, 38KG, MALE PATIENT THE SUCTION CATHETER WAS BEING USED CONTINUOUSLY. CASE STARTED WITH APPROPRIATE POSITIONING OF EZ BLOCKER UNDER VISION AND ISOLATION OF RIGHT LUNG WITH 6 CC AIR - FOLLOWED BY DEFLATING THE LUNG. PERI PROCEDURE, RIGHT LUNG STARTED VENTILATING PARTIALLY AND HENCE 2 CC AIR WAS ADDED IN THE CUFF. AFTER AN HOUR, THE LUNG STARTED GETTING VENTILATION AGAIN AND GOT INFLATED SLOWLY. THE ANESTHETIST VERIFIED THE CUFF POSITION AND ITS INFLATION BY FOB. ALTHOUGH EZB APPEARED FINE BUT LUNG ISOLATION WAS NOT POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1821568 EZ-BLOCKER KIT EZ BLOCKER CBI TELEFLEX MEDICAL IPN913391 10801902142372

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male NONE REPORTED| NONE REPORTED