BEUDAMED
    FDA Adverse Event Other Summary report: N

    KIMBERLY-CLARK MIC GASTROSTOMY FEEDING TUBE

    MDR report key: 1030552 · Received April 17, 2008

    Report

    Report Number
    9611594-2008-00004
    Event Type
    Other
    Date Received
    April 17, 2008
    Date of Event
    March 21, 2008
    Report Date
    April 16, 2008
    Manufacturer
    AVENT SA DE R.L. DE C.V.
    Product Code
    KNT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND TO BE DOCUMENTED. TO DATE, A ROOT CAUSE HAS NOT BEEN IDENTIFIED. INVESTIGATION PROCESS IS ON-GOING. A FOLLOW-UP REPORT WILL BE PROVIDED WHEN ADD'L RELEVANT INFO BECOMES AVAILABLE. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT & MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFO IS USED TO IDENTIFY THE NEED FOR ADD'L INVESTIGATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER BY THE USER FACILITY THAT THE LABEL ON THE BOX AND PACKAGE SAID THAT THE FEEDING TUBE WAS PRODUCT, BUT PRINTED ON THE DISK OF THE FEEDING TUBE. THE BUTTON WAS REMOVED AND REPLACED. THE USER FACILITY ALSO NOTED THAT AFTER MEASURING THE TUBE, IT WAS DISCOVERED THE LENGTH WAS 3.5CM. THERE WAS NO REPORT OF SERIOUS INJURY OR DEATH AS RESULT OF THIS PRODUCT PROBLEM. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED, BUT IS RELAYING THE INFO 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 FEEDING TUBE GASTROINTESTINAL TUBE AND ACCESSORIES KNT AVENT SA DE R.L. DE C.V. NA 418001

    Patients

    Seq Age Sex Outcome Treatment
    1