BEUDAMED
    FDA Adverse Event Summary report: N

    ENTRIFLEX FEEDING TUBES

    MDR report key: 1002167 · Received February 21, 2008

    Report

    Report Number
    1314412-2008-00002
    Date Received
    February 21, 2008
    Report Date
    February 4, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 02/08/08, I SPOKE WITH THE RISK MGR WHO STATED: "THE EVENT OCCURRED BETWEEN 3 MONTHS RANGE IN 2007. THE REASON THAT THIS COMPLAINT WAS ONLY REFERRED TO YOUR COMPANY ON 02/04/08 IS BECAUSE SHE HAS ONLY BEEN IN THE RISK MANAGEMENT POSITION FOR TWO MONTHS AND WAS REQUESTED BY LEADERSHIP TO REPORT THIS NOW." SHE DID NOT HAVE A LOT OF INFO OTHER THAN THAT THE PT WAS ELDERLY AND DID NOT NEED A CHEST TUBE. SHE ALSO STATED THAT: "THE HOSP DID A ROOT CAUSE ANALYSIS AND FOUND THAT THE NURSES WERE NOT USING LUBRICANT WITH THESE TUBES WHICH MAY HAVE CONTRIBUTED TO THE PNEUMOTHORAX."

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTH CARE/KENDALL ON 02/04/08 THAT A CUSTOMER HAD A PROBLEM WITH A FEEDING TUBE. CUSTOMER STATED THAT PT SUFFERED FROM A LUNG PUNCTURE WHILE INSERTING FEEDING TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRIFLEX FEEDING TUBES FEEDING TUBE FPD TYCO HEALTHCARE/KENDALL 8884721088 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR