BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD IMPRA VENAFLO W/CARBON STRAIGHT

    MDR report key: 258510 · Received January 14, 2000

    Report

    Report Number
    258510
    Event Type
    Injury
    Date Received
    January 14, 2000
    Date of Event
    December 22, 1999
    Report Date
    January 14, 2000
    Manufacturer
    *
    Product Code
    FIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A REVISION OF LEFT ARTERIAL VENOUS SHUNT, A HOLE IN GRAFT WAS NOTED. SHUNT REMOVED AND REPLACED WITH A DIFFERENT PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD IMPRA VENAFLO W/CARBON STRAIGHT VASCULAR GRAFT FIQ * REF# V5006C *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention