BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC* TRANSGASTRIC - JEJUNAL FEEDING TUBE KIT

    MDR report key: 1934738 · Received December 21, 2010

    Report

    Report Number
    9611594-2010-00107
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 13, 2010
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO REVIEW THE DEVICE HISTORY RECORD AS NO LOT NUMBER WAS PROVIDED.THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED TO KIMBERLY-CLARK FOR EVALUATION.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. THE DEVICE WAS NOT RETURNED BY THE CUSTOMER TO KIMBERLY-CLARK.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "PHYSICIAN PLACED THIS IN A PATIENT FOR TUBE FEEDING AND AFTER SEVERAL WEEKS THE END OF THE TUBE ERODED THROUGH THE SMALL BOWEL WALL EMPTYING TUBE FEEDS INTO THE PERITONEAL CAVITY. HE X-RAYED THE PATIENT AFTER PLACEMENT AND FELT THE TUBE WAS PLACED WELL. THE TUBE WAS PLACED APPROXIMATELY 5 WEEKS AGO. WHEN IT WAS REPORTED THE PATIENT GOT SICK, SURGERY WAS PERFORMED THE SAME DAY, (B)(6). THE PATIENT WAS IN THE ICU FOR A WEEK BUT IS CURRENTLY IN STABLE CONDITION ON THE FLOOR AND IS RECOVERING." 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 MIC TJ FEEDING TUBE KNT KIMBERLY-CLARK HEALTH CARE NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention