BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY

    MDR report key: 2854911 · Received November 21, 2012

    Report

    Report Number
    2854911
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 21, 2012
    Manufacturer
    KIMBERLY CLARK
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    G TUBE WAS OPENED FOR SURGICAL PLACEMENT. FOUND TO BE DEFECTIVE. THE PART THAT TOUCHES THE PATIENT WAS FLIPPED UPSIDE DOWN AND THERE WAS A VISIBLE HOLE IN THE BALLOON. SURGEON FOUND PROBLEM BEFORE PLACING IN PATIENT. ITEM SET ASIDE FOR RETURN TO THE MANUFACTURER AND OPENED A NEW G TUBE. PRODUCT AND PACKAGING SENT TO RISK. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC-KEY TUBE, FEEDING KNT KIMBERLY CLARK 0100-24 AA1283D05

    Patients

    Seq Age Sex Outcome Treatment
    1 *