BEUDAMED
    FDA Adverse Event Other Summary report: N

    KIMBERLY-CLARK MIC GASTROSTOMY FEEDING TUBE

    MDR report key: 1040903 · Received April 25, 2008

    Report

    Report Number
    9611594-2008-00005
    Event Type
    Other
    Date Received
    April 25, 2008
    Date of Event
    March 21, 2008
    Report Date
    April 25, 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
    CO, US
    Reporter Occupation
    RISK MANAGER

    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 ADDITIONAL 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 ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR BY MEDWATCH THAT A MIC TUBE THAT HAD BEEN PLACED FOR SEVERAL HOURS SLIPPED OUT COMPLETELY. THE PHYSICIAN NOTED THAT THE BALLOON ON THE TUBE WAS LEAKING FLUID WHICH CAUSED THE TUBE TO DISPLACE. THE PT HAD TO RETURN TO SURGERY FOR PLACEMENT OF A NEW FEEDING TUBE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIMBERLY-CLARK MIC GASTROSTOMY FEEDING TUBE GASTROINTESNTINAL TUBE AND ACCESSORIES KNT AVENT SA DE R.L. DE C.V. NA 426355

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other