BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT* MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS

    MDR report key: 1901194 · Received November 17, 2010

    Report

    Report Number
    1033422-2010-00020
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    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 WAS NOT RETURNED TO KIMBERLY-CLARK FOR EVALUATION. RISK MANAGEMENT AT THE FACILITY WAS HOLDING THE SAMPLE. 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. OTHER: DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK BY THE CUSTOMER FOR EVALUATION.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "AN ADULT MICROCUFF ETT WAS FOUND TO HAVE A LEAK IN THE CUFF. THERE WAS NO PATIENT INJURY REPORTED IN CONJUNCTION WITH THIS LEAK. THE TUBE HAS BEEN GIVEN TO THE HOSPITAL'S REGULATORY DEPT AND AFTER THEIR INVESTIGATION THEY WILL DECIDE IF THEY CAN RETURN THE TUBE TO KC." NO EXACT AGE GIVEN FOR PATIENT. 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 FOR ADULTS MICRO CUFF BTR KIMBERLY-CLARK HEALTH CARE NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1