BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY BUTTON 12F

    MDR report key: 2150473 · Received June 23, 2011

    Report

    Report Number
    2150473
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    March 31, 2011
    Report Date
    May 25, 2011
    Manufacturer
    KIMBERLY CLARK
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE PT'S ASSESSMENT, IT WAS NOTED THAT THE INFANT WAS AGITATED AND PUSHED AGAINST THE G-TUBE. MITTENS WERE INTACT ON THE PT'S HANDS. THE PT HAD PUSHED AGAINST THE TUBING WITH ARM AND G-TUBE CAME OUT OF THE SURGICAL SITE. UPON EXAMINATION, IT WAS NOTED THAT THE BALLOON WAS BROKEN AND NOT INTACT. THE CONTINUOUS FEEDINGS WERE STOPPED. A NEW DEVICE WAS INSERTED AND FEEDINGS WERE RESTARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC-KEY BUTTON 12F ENTERAL FEEDING TUBE KNT KIMBERLY CLARK * AA0186F03

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO