BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENFLO II VASCULAR GRAFT

    MDR report key: 1820556 · Received August 26, 2010

    Report

    Report Number
    2020394-2010-00267
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 3, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DSY
    PMA / PMN Number
    K052282
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE LOT MET ALL RELEASE CRITERIA. THE DHR REVIEW SHOWED THAT ALL PROCESS PARAMETERS WERE WITHIN SPECIFICATION. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER. THE SAMPLE HAS BEEN RETURNED FOR EVAL AND THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VASCULAR GRAFT IMPLANTED IN THE PT'S UPPER ARM, WAS PUNCTURED FOR DIALYSIS APPROXIMATELY ONE MONTH POST IMPLANT. A COUPLE OF WEEKS LATER, IT WAS OBSERVED THAT THE FUNCTION OF THE GRAFT WAS STRONGLY AFFECTED. THE GRAFT WAS THEN EXPLANTED DUE TO OCCLUSION AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENFLO II VASCULAR GRAFT DSY BARD PERIPHERAL VASCULAR, INC. VTUA1727

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention