BEUDAMED
    FDA Adverse Event Summary report: N

    KIMVENT CLOSED SUCTION SYSTEM FOR NEONATES

    MDR report key: 2853365 · Received November 30, 2012

    Report

    Report Number
    8030647-2012-00020
    Date Received
    November 30, 2012
    Date of Event
    June 1, 2012
    Report Date
    November 2, 2012
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, 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. A PORTION OF THE DEVICE WAS RETURNED TO KIMBERLY-CLARK FOR ANALYSIS. WE RECEIVED A 2.8CM OF CATHETER TUBING THAT APPEARS TO HAVE BEEN CUT FROM THE DISTAL END. THE DIRECTION FOR USE WARN, "DO NOT TRIM OR CUT THE ENDOTRACHEAL TUBE (NOT SUPPLIED) WHILE THE KIMVENT CLOSED SUCTION SYSTEM IS ATTACHED, OTHERWISE THE KIMVENT CATHETER MAY ALSO BE CUT AND THAT PORTION OF THE CATHETER MAY BE ASPIRATED INTO THE LOWER RESPIRATORY TRACT OF THE PATIENT AND MAY CAUSE DEATH OR SERIOUS INJURY." 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 FROM (B)(6), STATING, "THE BOTTOM (3 CM) TIP OF THE ENDOTRACHEAL CLOSED SUCTION CATHETER WAS FOUND IN THE PATIENT'S LUNG THIS HAD TO BE REMOVED WITH A BRONCHOSCOPE UNDER GENERAL ANAESTHESIA."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 CLOSED SUCTION SYSTEM FOR NEONATES CLOSED SUCTION CATHETER BSY KIMBERLY-CLARK HEALTH CARE NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1