BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT MULTI-ACCESS PORT CLOSED SUCTION SYSTEM FOR ADULTS

    MDR report key: 1905685 · Received November 23, 2010

    Report

    Report Number
    8030647-2010-00012
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 25, 2010
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORD IS PENDING. SAMPLE EVALUATION IS NOT COMPLETE AT THIS TIME. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE DHR REVIEW OR ONCE SAMPLES ARE EVALUATED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "DAMAGE TO BRONCHOSCOPE WHEN IT PASSES THROUGH THE SEAL CASSETTE DURING A TRACHEOTOMY. NO PATIENT INJURY. THE PATIENT HAD UNDERGONE AN ADDITIONAL BRONCHOSCOPE PROCEDURE AFTER THE TRACHEOTOMY, AND THE AIRWAY WAS CLEAR OF ANY FOREIGN OBJECTS. ADDITIONALLY, THE PATIENT WAS STABLE AND HAD BEEN FOR OVER 12 HOURS AFTER THE INITIAL PROCEDURE." KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMVENT MULTI-ACCESS PORT CLOSED SUCTION SYSTEM FOR ADULTS MAP CATHETER BSY KIMBERLY-CLARK HEALTH CARE M0258T802

    Patients

    Seq Age Sex Outcome Treatment
    1