BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC G-16 INTRODUCER KIT

    MDR report key: 3051436 · Received April 10, 2013

    Report

    Report Number
    9611594-2013-00038
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR ANALYSIS. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. 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 TO KIMBERLY-CLARK BY CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT FROM THE (B)(4) STATING, "AN ATTEMPT WAS MADE TO PUT A TRANSGASTRIC JEJUNAL TUBE IN USING A PRIMARY PLACEMENT INTRODUCER KIT . DURING THIS PROCEDURE THE SERIAL DILATOR CAME APART WHILE INSIDE THE PATIENT. THE END PART OF THE DILATOR BROKE AWAY FROM THE REST OF THE DILATOR INSIDE THE PATIENT'S STOMACH. THE GUIDEWIRE WAS IN PLACE AND WAS USED TO REMOVE THE BROKEN PART OF THE DILATOR. THE PATIENT WAS NOT INJURED. THERE WERE NO COMPLICATIONS PRIOR TO THE PROCEDURE AND THE TRANSGASTRIC JEJUNAL TUBE WAS NOT PLACED. A GASTROSTOMY TUBE WAS PLACED." 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
    149926 MIC G-16 INTRODUCER KIT ENTERAL FEEDING KIT KNT KIMBERLY-CLARK HEALTH CARE AA2163R04

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR