BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT MICROCUFF ENDOTRACHEAL TUBE

    MDR report key: 2193277 · Received August 5, 2011

    Report

    Report Number
    1033422-2011-00016
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO REVIEW THE DEVICE HISTORY RECORD AS NO LOT NUMBER WAS PROVIDED. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK BY THE CUSTOMER FOR ANALYSIS. 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, "THE RTS SEEM TO BE HAVING MORE PROBLEMS WITH THE MICRO-CUFF ET TUBE BEING TOO THIN AND FLEXING/KINKING. THEY HAD ONE CURL A TUBE IN THE PATIENT'S MOUTH AND EXTUBATED THEMSELVES." 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. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS RECORD (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMVENT MICROCUFF ENDOTRACHEAL TUBE MICROCUFF ET TUBE BTR KIMBERLY-CLARK HEALTH CARE NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention