BEUDAMED
    FDA Adverse Event Other Summary report: N

    VYGON DUODENAL SILICONE RUBBER FEEDING TUBE-5FR

    MDR report key: 36360 · Received August 30, 1996

    Report

    Report Number
    2245270-1996-00025
    Event Type
    Other
    Date Received
    August 30, 1996
    Date of Event
    August 22, 1996
    Report Date
    August 30, 1996
    Manufacturer
    VYGON S.A.
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TUBE WAS RETURNED BY THE HOSPITAL, IT WAS SENT TO FOREIGN CO AFFILIATE FOR EXAMINATION ON 9-11-96. AWAITING RESULTS OF THE ANALYSIS. DATA A1,A3,A4 & D10 NOT REPORTED TO CO. THIS SHOULD BE SOUGHT FROM THE HOSPITAL. A MICROSCOPIC EXAMINATION REVEALED THE TUBE HAD BEEN CUT WITH A SHARP INSTRUMENT. HAVE ASKED CLINICIAN TO CHECK WHETHER AN ABDOMINAL PROCEDURE WAS CARRIED OUT WHICH COULD HAVE CAUSED THE TUBE TO BE INADVERTENTLY CUT.

    Description of Event or Problem · 1

    TUNGSTEN WEIGHT WAS SEEN ON X-RAY TO BE OUTSIDE THE SILICONE RUBBER FEEDING TUBE. THE TUBE HAS BEEN REMOVED. THE BABY IS BEING MONITORED TO SEE IF THE TUNGSTEN WEIGHT WILL PASS THROUGH THE SYSTEM WITH THE BABY'S FECES. THE TUBE WAS ONLY ON 3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VYGON DUODENAL SILICONE RUBBER FEEDING TUBE-5FR Implant SILICONE RUBBER DUODENAL FEEDING TUBE FPD VYGON S.A. 2395.05 261291EE OR 250494EE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization BEING RETURNED.