BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENTRIFLEX FEEDING TUBE

    MDR report key: 371800 · Received January 14, 2002

    Report

    Report Number
    1314412-2002-00001
    Event Type
    Other
    Date Received
    January 14, 2002
    Date of Event
    January 8, 2002
    Report Date
    January 14, 2002
    Manufacturer
    KENDALL COMPANY
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002 AND ONE DAY THE PREVIOUS WEEK A FEEDING TUBE ALLEGEDLY PUNCTURED A LUNG. PHYSICIAN FELT NO RESISTANCE. PNEUMOTHORAX PRODUCED ON BOTH OCCASIONS. PROCEDURE WAS NOT PERFORMED UNDER X-RAY. BOTH PATIENTS RECEIVED A CHEST TUBE. SAME PHYSICIAN PERFORMING INSERTION BOTH TIMES. KENDALL NOTIFIED THE FOLLOWING DAY OF BOTH INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRIFLEX FEEDING TUBE FEEDING TUBE FPD KENDALL COMPANY * U117203

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention