BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KEOFEED TUBE

    MDR report key: 4231807 · Received October 31, 2014

    Report

    Report Number
    MW5038967
    Event Type
    Injury
    Date Received
    October 31, 2014
    Date of Event
    August 8, 2014
    Report Date
    October 31, 2014
    Manufacturer
    CORPAK
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT 4 HAD A FEEDING TUBE MISPLACED ON (B)(6) 2014 AT (B)(6) HOSPITAL. CORTRAK SYSTEM WAS USED TO PLACE FEEDING TUBE ON (B)(6) 2014 AND THE TUBE WAS PLACED IN THE LUNG IN ERROR. TUBE WAS REMOVED AND A NEW TUBE WAS PLACED USING THE CORTRAK SYSTEM ON (B)(6) 2014. MEDICATIONS AND TUBE FEEDING WERE ADMINISTERED THROUGH THE TUBE PRIOR TO THE DISCOVERY THAT THE TUBE WAS IN THE CHEST CAVITY. PATIENT 4 HAD A DECLINE IN RESPIRATORY STATUS AND BECAME FEBRILE. THE TUBE WAS REMOVED, BUT SHORTLY THEREAFTER, THE PATIENT'S VITAL SIGNS CONTINUED TO DECLINE AND HE REQUIRED A CODE BLUE RESUSCITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698518 KEOFEED TUBE KEOFEED TUBE FPD CORPAK
    698519 KEOFEED TUBE KEOFEED TUBE FPD CORPAK

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Life Threatening