BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROVASIVE TTP JEJUNOSTOMY TUBES

    MDR report key: 630440 · Received August 26, 2005

    Report

    Report Number
    6000048-2005-00117
    Event Type
    Injury
    Date Received
    August 26, 2005
    Date of Event
    August 3, 2005
    Report Date
    August 10, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT DURING A THERAPEUTIC PROCEDURE PERFORMED IN 2005, A TTP J-TUBE ENTERAL FEEDING DEVICE WAS PLACED AT THE INTESTINE DUODENUM OF A PATIENT, AFTER THE CLINICIANS REPLACED THE SECURI-T WITH A FASTRACKER. DURING THE PLACEMENT, THE TIP OF THE TUBE WAS PLACED A LITTLE OVER THE DUODENAL BULB, AS IT WAS EXPECTED THAT PERISTALIC MOTION WOULD HELP THE POSITION. IN 5 DAYS LATER THE J-TUBE THAT EAS FOUND TO BE MISSING, BUT WAS LOCATED UNDER X-RAY INSIDE THE PATIENT'S STOMACH. THE J-TUBE WAS THEN REMOVED WITH THE AID OF A SNARE. THE FEEDING TUBE WAS THEN EXCHANGED TO AN INTRAVENOUS HYPERALIMENTATION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVASIVE TTP JEJUNOSTOMY TUBES ENTERAL FEEDING DEVICES KNT BOSTON SCIENTIFIC CORP. NA 7463497

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention