BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRIFLEX FEEDING TUBE

    MDR report key: 80750 · Received April 3, 1997

    Report

    Report Number
    2242547-1997-00008
    Event Type
    Injury
    Date Received
    April 3, 1997
    Date of Event
    March 4, 1997
    Report Date
    March 5, 1997
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NURSES ON TWO DIFFERENT SHIFTS ATTEMPTED TO INSERT THE FEEDING TUBE INTO AN INTUBATED PT FOUR TIMES ON MONDAY 3/3/97. INCORRECT PLACEMENT WAS CONFIRMED BY X-RAY ON EACH OF THE FOUR ATTEMPTS. THE STYLET WAS NEVER REMOVED. ON TUESDAY 3/4/97, NURSES AGAIN ATTEMPTED PLACEMENT. DURING THE TWO ATTEMPTS THEY USED A FEEDING TUBE WITH STYLET. THEY CHILLED THE TUBE FOR GREATER RIGIDITY. FIRST TUBE WAS INSERTED AND THEY WERE UNABLE TO REPOSITION AS INDICATED BY X-RAY; THE TUBE WAS REMOVED. NEW TUBE WAS INSERTED, POSITION ON X-RAY SHOWED TUBE CURLED UP INTO RIGHT UPPER LOBE OF LUNG. THE PNEUMOTHORAX WAS CONFIRMED BY X-RAY. THE PT WAS TREATED USING A CDU AND IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRIFLEX FEEDING TUBE FEEDING TUBE FPD SHERWOOD DAVIS AND GECK NA 979201

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention ETT, ARTERIAL LINE, CARDIAC MONITORING