BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY LOW-PROFILE-JEJUNAL FEEDING TUBE

    MDR report key: 1133462 · Received August 22, 2008

    Report

    Report Number
    9611594-2008-00007
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    December 1, 2007
    Report Date
    August 22, 2008
    Manufacturer
    AVENT SA DE R.L. DE C.V.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WILL BE SENT FOR EVALUATION AND THOROUGH INVESTIGATION OF INCIDENT DEVICE COULD NOT BE CONDUCTED. THE PRODUCTION HISTORY FOR THIS PRODUCT CODE WAS REVIEWED FINDING NO SIMILARITIES TO BE DOCUMENTED EVALUATION OF THE MANUFACTURING PROCESS FOUND NO AREAS OR TOOLS THAT COULD CAUSE THIS FAILURE MODE. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT & MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO THE MANUFACTURER BY THE PATIENT THAT 2007, AFTER WEARING THE MIC-KEY LOW PROFILE JEJUNAL FEEDING TUBE FOR 6 MONTHS, THE TUBE REPORTEDLY DISINTEGRATED AND TO BE REMOVED SURGICALLY WITH A TWEEZER AND FLUSHING. A BIG PART OF THE TUBE WAS REPORTED TO HAVE GONE INTO THE INTESTINE BUT PASSED WITHOUT ANY FURTHER INTERVENTION. THE USER REPORTED THAT THERE WAS NO INJURY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC-KEY LOW-PROFILE-JEJUNAL FEEDING TUBE JEJUNAL FEEDING TUBES KNT AVENT SA DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention