BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG 9.5 FR D/L CATHETER

    MDR report key: 205697 · Received January 4, 1999

    Report

    Report Number
    1720496-1999-00001
    Event Type
    Malfunction
    Date Received
    January 4, 1999
    Date of Event
    November 16, 1998
    Report Date
    November 17, 1998
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLACED 11/13/1998 AND REMOVED 11/16/1998 DUE TO LEAKAGE OF TOTAL PARENTERAL NUTRITION & INTRAVENOUS MEDS INTO SUBCUTANEOUS TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG 9.5 FR D/L CATHETER Implant LONG TERM INTRAVASCULAR CATHETER DQO BARD ACCESS SYSTEMS 0603622 36GH2458

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention