BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP

    MDR report key: 2840609 · Received November 20, 2012

    Report

    Report Number
    3005099803-2012-05335
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 25, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K081739
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT UPN AND DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. THE REPORTED EVENT OF J-TUBE CRACKED. THE REPORTED EVENT OF J-TUBE LEAKED INTO GASTRIC PROBE. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE TWO-PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR THE ADVANCED STAGE PARKINSON'S DISEASE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, ON (B)(6) 20120, THE J-TUBE CRACKED AND ITS CONTENTS LEAKED INTO THE PEG TUBE. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER UNK443

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DUODOPA