BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4FR POLY PQC TRAY

    MDR report key: 475301 · Received July 21, 2003

    Report

    Report Number
    1720496-2003-00112
    Event Type
    Malfunction
    Date Received
    July 21, 2003
    Date of Event
    June 24, 2003
    Report Date
    June 24, 2003
    Manufacturer
    BARD REYNOSA S.A. DE C.V.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CLOT HAD FORMED ON THE OUTSIDE OF THE PICC. PICC WAS REMOVED, WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4FR POLY PQC TRAY IMPLANTED LONG TERM INTRAVASCULAR CATHETER LJS BARD REYNOSA S.A. DE C.V. 3144100 22DN3869

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention