BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY LOW PROFILE GASTROSTOMY FEEDING TUBE, 18 FRENCH

    MDR report key: 2842878 · Received November 21, 2012

    Report

    Report Number
    9611594-2012-00137
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    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 DISCARDED BY USER AND NOT AVAILABLE TO KIMBERLY-CLARK FOR EVALUATION. THE DEVICE LABEL STATES,"DO NOT USE IF PACKAGE DAMAGED." 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 WAS NOT RETURNED TO KIMBERLY-CLARK BY CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, HOME HEALTH NURSE WENT TO REPLACE PATIENT'S TUBE YESTERDAY, AND WHEN SHE OPENED THE OUTSIDE BOX, WHICH WAS TAPED, THE INSIDE BLISTER PACK WASN'T SEALED. THE NURSE CONSULTED WITH THE PATIENT'S PHYSICIAN AND IT WAS DECIDED TO USE THE TUBE, EVEN THOUGH IT WAS OPENED, AS GASTRIC CONTENTS WERE LEAKING FROM THE STOMA. THE TUBE WAS REPLACED AS SOON AS ANOTHER ONE COULD BE SECURED FROM THE PHYSICIAN'S OFFICE. NO REPORT OF PATIENT INJURY. 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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC-KEY LOW PROFILE GASTROSTOMY FEEDING TUBE, 18 FRENCH GASTRIC FEEDING TUBE KNT KIMBERLY-CLARK HEALTH CARE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR