BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS, 8.0

    MDR report key: 2974897 · Received February 22, 2013

    Report

    Report Number
    1033422-2013-00008
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 FOR THE DEVICE INVOLVED IN THIS REPORTED EVENT. KIMBERLY-CLARK RECEIVED TWO ENDOTRACHEAL TUBES FOR ANALYSIS. BOTH TUBE EXHIBIT RADIAL BURSTS ON THE CUFF. THE INVESTIGATION OF THIS REPORTED EVENT IS ONGOING. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, 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, "FACILITY HAS HAD AN ISSUE WHERE THE CUFF OF THE ET TUBE HAS BURST AND PATIENT HAD TO BE REINTUBATED." 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78539 KIMVENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS, 8.0 ENDOTRACHEAL TUBE BTR KIMBERLY-CLARK HEALTH CARE NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1