BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIC-KEY LOW PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE

    MDR report key: 3091014 · Received May 3, 2013

    Report

    Report Number
    9611594-2013-00054
    Event Type
    Death
    Date Received
    May 3, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, 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 FOR THE DEVICE INVOLVED IN THIS REPORTED EVENT. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR EVALUATION, THEREFORE WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. WE HAVE CONTACTED THE USER FACILITY AND ARE WAITING FOR A REPLY. IF WE RECEIVE ANY ADDITIONAL RELEVANT INFORMATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A FOLLOW-UP REPORT. 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. (B)(4): DEVICE NOT RETURNED TO KIMBERLY-CLARK BY CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "THERE WAS A PATIENT WHO EXPERIENCED A PERFORATED BOWEL DURING INTERVENTIONAL RADIOLOGY(IR) PLACEMENT OF A TJ TUBE OVER THE GUIDE WIRE. THE PATIENT HAD TO HAVE BOWEL REPAIR AFTER THE INITIAL IR PROCEDURE. THE PATIENT IS NOW DECEASED." 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
    193881 MIC-KEY LOW PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE ENTERAL FEEDING TUBE KNT KIMBERLY-CLARK HEALTH CARE NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Death