BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY LOW PROFILE GASTROSTOMY FEEDING TUBE

    MDR report key: 3051047 · Received April 10, 2013

    Report

    Report Number
    9611594-2013-00036
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 11, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 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.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "THE TUBE SHEARED OFF BELOW THE HEAD. DISTAL TUBE REMAINS IN THE GI TRACT AND MOTHER IS WAITING FOR IT TO PASS RECTALLY." 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153516 MIC-KEY LOW PROFILE GASTROSTOMY FEEDING TUBE ENTERAL FEEDING TUBE KNT KIMBERLY-CLARK HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR