BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIC TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT

    MDR report key: 1930431 · Received December 16, 2010

    Report

    Report Number
    9611594-2010-00094
    Event Type
    Death
    Date Received
    December 16, 2010
    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 FOR (B)(4) WITH LOT NUMBER AA9236N17 WAS REVIEWED, WITH NO SIMILAR OBSERVATIONS NOTED BY THE QUALITY AUDITOR. NO SAMPLE WAS RETURNED TO KIMBERLY-CLARK FOR EVALUATION. THE DIRECTIONS FOR USE CAUTION "THE LENGTH OF THE TUBE SHOULD BE SUFFICIENT TO BE PLACED 10-15CM BEYOND THE LIGAMENT OF TREITZ." ALSO PER DFU, "VERIFY PROPER TUBE PLACEMENT RADIOGRAPHICALLY TO AVOID POTENTIAL COMPLICATION (E.G. BOWEL IRRITATION OR PERFORATION) AND ENSURE THE TUBE IS NOT LOOPED WITHIN THE STOMACH OR SMALL BOWEL." 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 NOT RETURNED BY CUSTOMER TO KIMBERLY-CLARK.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT FROM (B)(6), STATING, "THE GASTROJEJUNOSTOMY TUBE ((B)(4), LOT 9236N17 AA) WAS PLACED WITHOUT DIFFICULTY, TO REPLACE A BUTTON IMPLEMENTED IMMEDIATELY WITH NEW GASTROPEXY (2 STITCHES). THE PATIENT DEVELOPED SEPTIC SHOCK WITH RAPID DETERIORATION OF CLINICAL STATUS, 12 TO 24 HOURS AFTER THE PLACEMENT OF THE TUBE. LAPAROTOMY PERFORMED IN EMERGENCY IN A CONTEXT OF SEPTIC SHOCK SHOWED A PERFORATION OF THE SMALL INTESTINE AT THE LIGAMENT OF TREITZ. THE EVOLUTION WAS MARKED BY THE DETERIORATION OF THE CHILD IN THE ICU AND HIS DEATH FOUR DAYS AFTER THE PLACEMENT OF THE PROBE. TUBE WAS PLACED JUST AT THE ANGLE OF TREITZ." 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
    1 MIC TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT TJ FEEDING TUBE KNT KIMBERLY-CLARK HEALTH CARE AA9236N17

    Patients

    Seq Age Sex Outcome Treatment
    1 Death