BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6FR FEEDING TUBE

    MDR report key: 2110889 · Received May 13, 2011

    Report

    Report Number
    2245270-2011-00031
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    January 3, 2011
    Report Date
    May 13, 2011
    Manufacturer
    VYGON
    Product Code
    FPD
    PMA / PMN Number
    K060944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS A USER FACILITY MEDWATCH THAT VYGON RECEIVED FROM FDA. VYGON REGULATORY AFFAIRS CONTACTED THE HOSPITAL FOR ADDITIONAL INFO FOR THIS REPORT AS WELL AS TO REQUEST THE DEVICE. THE HOSPITAL ADVISED THEY WOULD SEND THE USED DEVICE FOR EVAL. VYGON EXPECTS TO RECEIVE THE DEVICE THE WEEK OF MAY 16TH. ONCE COMPLAINT HAS BEEN FULLY INVESTIGATED, VYGON WILL SUBMIT RESULTS TO FDA IN A FOLLOW UP MDR WITHIN 1 MONTH OF RECEIVING THE NEW INFO.

    Description of Event or Problem · 1

    THE RN WAS ATTEMPTING TO PLACE A 6F FEEDING TUBE FOR GO LYTELY ADMINISTRATION FOR A BOWEL PREP WITH HELP OF ANOTHER RN. THE RN MEASURED THE TUBE FOR PLACEMENT, LUBRICATED THE TUBE AND ATTEMPTED TO PASS THE TUBE VIA THE RIGHT NOSTRIL. THE RN MET WITH RESISTANCE AND REMOVED THE TUBE. UPON REMOVAL, THE RN NOTED A SMALL AMOUNT OF BRIGHT RED BLOOD IN THE TUBE AND AROUND THE NARE AND NOTED THE TIP OF THE TUBE WAS NO LONGER PRESENT (APPROX 1 MM WAS GONE, AS CITED BY THE RN). THE PT REMAINED PINK, WARM AND WELL PERFUSED THROUGHOUT AND AFTER THE PROCEDURE. A CHEST XRAY WAS ORDERED AND IT WAS VERIFIED THAT NO PIECES OF THE TUBE FELL INTO THE LUNGS AS THE XRAY WAS CLEAR. NO HARM OCCURRED TO THE (B)(6) AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6FR FEEDING TUBE CATHETER, PICC FPD VYGON 311.06 130703FO

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO