BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT* MICROCUFF* ENDOTRACHEAL TUBE

    MDR report key: 1953228 · Received January 7, 2011

    Report

    Report Number
    1033422-2011-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    WE WERE UNABLE TO REVIEW THE DEVICE HISTORY RECORD AS NO LOT NUMBER WAS PROVIDED.THE SAMPLE HAS NOT YET BEEN RETURNED TO KIMBERLY-CLARK BY THE CUSTOMER.IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED ONCE THE SAMPLE IS 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. DEVICE HAS NOT YET ARRIVED AT KIMBERLY-CLARK FOR EVALUATION.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING,"THE PILOT LINE WAS BROKEN BECAUSE OF THE PATIENT BITING THROUGH IT." FOLLOW UP WITH SALES, SALES STATES "THE PATIENT WAS INTUBATED ORALLY AND THE TUBE IS ON ONE SIDE OF THE MOUTH AND THE PILOT LINE ON THE OTHER SIDE. PATIENT IS NOT FULLY SEDATED AND IS WORKING THEIR JAW AND EVENTUALLY CHEWS THROUGH THE INFLATION LINE CAUSING A CUFF LEAK. NO PATIENT INJURY, REQUIRED RE-INTUBATION" 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 MICRO CUFF ET TUBE BTR KIMBERLY-CLARK HEALTH CARE NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention