BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMVENT 8FR Y ADAPTER 12IN/30.5CM (LIGHT BLUE)

    MDR report key: 3850064 · Received June 4, 2014

    Report

    Report Number
    8030647-2014-00011
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 8, 2014
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR EVALUATION, THEREFORE WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. 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 NOT RETURNED TO KIMBERLY-CLARK.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT FROM (B)(6) STATING, " NURSE ATTACHED THE ENTERAL FEEDING CONNECTOR TO LAVAGE PORT AND INITIATED FEED VIA (B)(4) DEVICE. IMMEDIATELY NOTICED AND SUCTIONED FEED FROM ETT. NO INJURY TO BABY, FEEDING DID NOT ENTER LUNGS AS IT WAS CAUGHT VERY QUICKLY, AND NO MEDICAL INTERVENTION NEEDED." 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 COMPLAINT COMP-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326231 KIMVENT 8FR Y ADAPTER 12IN/30.5CM (LIGHT BLUE) CLOSED SUCTION TRACH CARE SYSTEM BSY KIMBERLY-CLARK HEALTH CARE 198 ANP

    Patients

    Seq Age Sex Outcome Treatment
    1