BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG 4 FR MIDLINE

    MDR report key: 212890 · Received March 1, 1999

    Report

    Report Number
    1720496-1999-00052
    Event Type
    Malfunction
    Date Received
    March 1, 1999
    Date of Event
    January 27, 1999
    Report Date
    January 29, 1999
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PLACED 1/25/1999 & A LEAK WAS NOTED 1/27/1999 AT THE INSERTION SITE. DISCONTINUED ANTIBIOTICS NORMAL SALINE BEING INFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG 4 FR MIDLINE Implant LONG TERM INTRAVASCULAR CATHETER DQO BARD ACCESS SYSTEMS 7715412 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention