BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE SAFETY PEG KIT

    MDR report key: 1222870 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06103
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Report Date
    October 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNK. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE IS NOT AVAILABLE FOR RETURN. THE DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: DATE OF EVENT IS UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NURSE AT THE PATIENT'S HOME EXPERIENCED PROBLEMS WITH LEAKING AT THE "SIDE PORT" (WHICH WAS BEING USED TO DELIVERY MEDICATION) OF THE ENDOVIVE SAFETY PEG DEVICE. ACCORDING TO THE COMPLAINANT, THE NURSE STATED THAT "THE SIDE PORT IS SPLIT DOWN THE SIDE AND LEAKS AND THAT THE CAP TO THE TOP PORT IS ALMOST BROKEN OFF". THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE SAFETY PEG KIT KNT BOSTON SCIENTIFIC CORPORATION M00566460 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK