BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JPP SILICONE SET HF

    MDR report key: 604747 · Received May 19, 2005

    Report

    Report Number
    2032582-2005-00001
    Event Type
    Injury
    Date Received
    May 19, 2005
    Date of Event
    April 19, 2005
    Report Date
    May 19, 2005
    Manufacturer
    PFM MEDICAL
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PFM MEDICAL VASCULAR ACCESS DEVICE IMPLANTED IN 2005 RIGHT INTERNAL JUGULAR. NINETEEN DAYS LATER THE ONCOLOGIST WAS UNABLE TO ACCESS, X-RAY INDICATED THE CATHETER HAD BECOME DISCONNECTED FROM THE RESERVOIR AND MIGRATED INTO THE SUPERIOR VENA CAVA EXTENDING INTO THE INFERIOR VENA CAVA. THIS CATHETER WAS REMOVED BY INTERVENTIONAL RADIOLOGY VIA GROIN APPROACH. FIVE DAYS LATER THE RESERVOIR WAS REMOVED. THE MECHANISM USED TO LOCK THE CATHETER TO THE RESERVOIR WAS INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JPP SILICONE SET HF VASCULAR ACCESS DEVICE DQO PFM MEDICAL 61.646.31.080.A 0420 CS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention