BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE

    MDR report key: 3630622 · Received February 17, 2014

    Report

    Report Number
    9611594-2014-00014
    Event Type
    Injury
    Date Received
    February 17, 2014
    Date of Event
    September 25, 2013
    Report Date
    December 23, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND DOCUMENTED THAT THE PRODUCT LOT REPORTED IN THE INCIDENT MET MANUFACTURING SPECIFICATIONS. ONE SAMPLE WAS RETURNED. THE LOT NUMBER ON THE STRAP IS AA3140F08. THE BALLOON EXHIBITS AN AXIAL BURST. EXTENDING IN A STRAIGHT LINE FROM THE BASE OF THE PROXIMAL COLLAR TO THE DISTAL TIP. THE BALLOON MATERIAL WAS INSPECTED UNDER MAGNIFICATION AND NO ROOT CAUSE COULD BE DETERMINED. 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

    KIMBERLY-CLARK RECEIVED A REPORT FROM (B)(6), STATING, ¿WE PLACED A GASTROSTOMY BUTTON, UNDER GENERAL ANESTHESIA, ON A (B)(6) CHILD ENDOSCOPICALLY. ON THE (B)(6) 2013 AT 6:00AM, IT WAS TAKEN OUT AND IT WAS NOTED THAT THE BALLOON WAS PIERCED. THE INFANT HAD PERITONITIS AND THE NURSE PERFORMED AN ACCIDENTAL INTRAPERITONEAL INFUSION OF MILK BETWEEN THE HOURS OR 2:00AM AND 6:00AM. THE LITTLE GIRL IS OKAY NOW. SHE HAS BEEN OPERATED ON FOR PERITONITIS. DURING THE INTERVENTION, THEY HAVE FOUND A PERIVISCERITIS AND A MECKEL DIVERTICULA. SO THEY MADE A RESECTION OF THE DIVERTICULA AND AN APPENDECTOMY WAS PERFORMED. THEY PERFORMED A DRAINAGE OF THE PERITONEAL CAVITY. THEY ALSO PERFORMED ANOTHER GASTROSTOMY.¿ 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100674 MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE ENETERAL FEEDING TUBE KNT KIMBERLY-CLARK HEALTH CARE AA3140F08

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO