BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIMBERLY-CLARK GJ FEEDING TUBE

    MDR report key: 5020687 · Received August 21, 2015

    Report

    Report Number
    5020687
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    August 18, 2015
    Report Date
    August 20, 2015
    Manufacturer
    HAYLARD HEALTH INC
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS A GJ TUBE. PARENTS STATED IT FLUSHED WELL IN THE AM BUT WHEN THEY FLUSHED LATER IN THE DAY, IT WAS FOUND TO LEAK. PATIENT CAME TO CLINIC WHERE IT WAS DISCOVERED IT HAD BROKEN OFF. PATIENT HAD TO GO TO OR TO HAVE REMAINING PIECE REMOVED. AT THE TIME OF EVENT WAS NOT USING GJ REGULAR FOR FEEDS. PATIENT WAS TAKING ALL ORAL MEDS ACCORDING TO PARENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553542 KIMBERLY-CLARK GJ FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT HAYLARD HEALTH INC AA4078N23

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other UNKNOWN SIZE SYRINGE