BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT, 22 F

    MDR report key: 2241913 · Received September 9, 2011

    Report

    Report Number
    9611594-2011-00109
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 11, 2011
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWS THE PRODUCT MET MANUFACTURING SPECIFICATIONS. THE DESCRIPTION OF THE EVENT PROVIDED BY THE REPORTER DID NOT CLEARLY DEFINE A SPECIFIC FAILURE OF THE DEVICE, AND ADDITIONAL DETAILS ABOUT THIS EVENT COULD NOT BE OBTAINED. IN ADDITION, THE INVOLVED DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LIMITED INFORMATION PROVIDED, INVOLVEMENT OF THE DEVICE IN THE REPORTED SEPARATION OF THE STOMACH FROM THE ABDOMINAL WALL COULD NOT 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. DEVICE WAS NO RETURNED TO KIMBERLY-CLARK BY THE CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT FROM (B)(6) STATING, "CUSTOMER WAS USING 0650-22J TO REPLACE THE COMPETITOR'S BUTTON TUBE AND FOUND 0650-22J'S GUIDE WIRE WAS INSERTED INTO ABDOMINAL CAVITY. DOCTOR WAS REMOVE THE COMPETITOR'S TUBE FIRST (BOSTON 20 FR) THEN INSERT KC'S GUIDE WIRE INTO STOMACH FISTULA UNDER FLUOROSCOPY. HOWEVER, DOCTOR COULD NOT FOUND TOP OF GUIDE WIRE IN PYLORUS BY FLUOROSCOPY. THEN PATIENT WAS MOVE TO ENDOSCOPE ROOM TO CONFIRM THE INSIDE OF BODY BY ENDOSCOPE, AND COULD NOT CONFIRM TOP OF GUIDE WIRE IN THE STOMACH BUT ASSUME IN THE ABDOMINAL CAVITY. THEN PATIENT'S OXYGEN SATURATION DECREASED (UNDER 90) AND BECOME UNCONSCIOUS. DOCTOR WAS MENTIONED IT COULD BE GAVE TOO MUCH MEDICINE. HOWEVER, AT FINALLY PATIENT WAS RECOVERY AFTER MOVE TO ER." 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 AS RECORD (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT, 22 F TRANSGASTRIC-JEJUNAL FEEDING TUBE KNT KIMBERLY-CLARK HEALTH CARE AA0305N27

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention