BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURASPAN HEMODIALYSIS CATHETER

    MDR report key: 1876636 · Received September 28, 2010

    Report

    Report Number
    1876636
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 28, 2010
    Manufacturer
    R4 VASCULAR INC.
    Product Code
    MSD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTED FOR DIALYSIS. THE SESSION WAS UNABLE TO BEGIN BECAUSE THE (BLUE) HUB OF THE VENOUS PORT WAS LOOSE WITHOUT LEAKAGE. INTERVENTIONAL RADIOLOGY DETERMINED THAT THE CATHETER HAD TO BE EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURASPAN HEMODIALYSIS CATHETER VASCULAR HEMODIALYSIS CATHETER MSD R4 VASCULAR INC. * R403D140P

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR NO OTHER THERAPIES| DIALYSIS