BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC J,TJ-18 INTRODUCER KIT

    MDR report key: 3013430 · Received March 20, 2013

    Report

    Report Number
    9611594-2013-00030
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 18, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND DOCUMENTED THAT THE PRODUCT LOT REPORTED IN THE INCIDENT MET MANUFACTURING SPECIFICATIONS. A SAMPLE WAS RETURNED TO KIMBERLY-CLARK FOR ANALYSIS. VISUAL INSPECTION NOTED THE SAMPLE RECEIVED INCLUDED ONE APPARENTLY UNUSED GASTROPEXY SAMPLE. 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.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "WHILE PLACING A MIC G-TUBE, TWO OF THE SUTURES BROKE DURING INSERTION OF THE MIC-J INTRODUCER. THE T-FASTENERS WERE DEPLOYED WITHOUT DIFFICULTY. NO OTHER KIT WAS NEEDED, THE SUTURES BROKE WHEN THE SERIAL DILATOR AND THE PEELAWAY WAS INSERTED. ONCE THE G-TUBE WAS INSERTED, THE BALLOON WAS INFLATED AND THE PEELAWAY WAS REMOVED. THE BALLOON WAS PULLED TO THE OSTOMY SITE. THE PROCEDURE WAS COMPLETED BY THE PHYSICIAN WITHOUT FURTHER EVENT." 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
    116576 MIC J,TJ-18 INTRODUCER KIT INTRODUCER KIT KNT KIMBERLY-CLARK HEALTH CARE AA2310R08

    Patients

    Seq Age Sex Outcome Treatment
    1