BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMBERLY CLARK MIC GASTROSTOMY TUBES

    MDR report key: 1190693 · Received October 3, 2008

    Report

    Report Number
    9611594-2008-00014
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    August 27, 2008
    Report Date
    October 2, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT SAMPLE HAS NOT BEEN RECEIVED. THE DEVICE HISTORY RECORD FOR THIS PRODUCT CODE HAS BEEN REVIEWED FINDING NO ANOMALIES TO BE DOCUMENTED. A THOROUGH INVESTIGATION COULD NOT BE PERFORMED WITHOUT THE INCIDENT SAMPLE. MEDICAL EVALUATION BY THE KIMBERLY CLARK MEDICAL DIRECTOR IS AS FOLLOWS: IMMEDIATE PERI-PROCEDURAL FAILURE MAY BE A RESULT OF MANY FACTORS INCLUDING IMPROPER SIZING, INADEQUATE BALLOON INFLATION, DAMAGE TO THE BALLOON EITHER PRIOR TO USE OR DURING PLACEMENT ESPECIALLY IF THE PATIENT IS THIN AND NEEDLES OR GRASPERS ARE UTILIZED WHICH COULD CREATE PUNCTURES. IF THE STOMA SITE HAS NOT BEEN ESTABLISHED (THIS TAKES UP TO SEVERAL WEEKS) IT IS NECESSARY TO RETURN TO THE IR SUITE OR OPERATING ROOM FOR SAFE REPLACEMENT. IN-PROCESS EVALUATION OF THE MANUFACTURING FOR THIS PRODUCT CODE FOUND NO TOOLS THAT COULD CAUSE THIS TYPE OF DAMAGE. NEW FUNCTIONAL INSPECTION METHODS OF PIPES DEVICES HAVE BEEN IMPLEMENTED TO IDENTIFY PINHOLES OR SPLITS ON THE FEEDING TUBE LUMEN. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. 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

    IT HAS BEEN REPORTED BY A KIMBERLY CLARK SALES REPRESENTATIVE THAT A TUBE PLACED IN A PATIENT IN 2008 STARTED LEAKING AND NEEDED TO BE REPLACED WITHIN TWO DAYS. IT WAS REPORTED THAT THERE WAS ALLEGEDLY A SLIT OF 5 INCHES ABOVE THE BALLOON. THERE WAS NO REPORT OF SERIOUS INJURY OR DEATH AS A RESULT OF THE PRODUCT PROBLEM. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY CLARK MIC GASTROSTOMY TUBES ENTERAL FEEDING TUBES KNT AVENT SA DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention