BEUDAMED
    FDA Adverse Event Other Summary report: N

    NIAGRA PC D/L 20CM KIT

    MDR report key: 285131 · Received July 3, 2000

    Report

    Report Number
    1720496-2000-00467
    Event Type
    Other
    Date Received
    July 3, 2000
    Date of Event
    May 19, 2000
    Report Date
    May 31, 2000
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO SMALL HOLES FOUND IN THE CATHETER'S ARTERIAL CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIAGRA PC D/L 20CM KIT HEMODIALYSIS NON-IMPLANTED MPB BARD ACCESS SYSTEMS 5594200 22FJ0405

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention