BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE

    MDR report key: 2249782 · Received September 12, 2011

    Report

    Report Number
    MW5022216
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 31, 2011
    Report Date
    September 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO (B)(6) ON (B)(6) 2011. EXPIRED (B)(6) 2011. (HOSPITALIZED FOR 2 MONTHS). FLAVOBACTERIUM MENINGOSEPTICUM (ELIZABETHKINGIA MENINGOSEPTICUM) ISOLATED FROM 2 PERIPHERAL BLOOD CULTURE SPECIMENS - FIVE (5) DAYS AFTER PEG INSERTION IN OPERATING ROOM WITH PRODUCTS FROM BOSTON SCIENTIFIC DISPOSABLE "STANDARD PEG KIT 'ENDO VIVE'" CONTAINING 'STERILE' APLICARE, INC. POVIDONE IODINE SWAB STICKS (3 PACK). PRODUCT LOCATED IN BOSTON SCIENTIFIC STANDARD PEG KIT 'ENDO VIVE' PULL METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE STANDARD PEG KIT KNT BOSTON SCIENTIFIC 14330940

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other APLICARE: EXP DATE 01/2114| APLICARE: LOT# B-1A193| THREE-PACK IODINE SWABS| APLICARE, INC. (B)(4)