BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROSHONG 3 FR PICC

    MDR report key: 150163 · Received February 19, 1998

    Report

    Report Number
    1720496-1998-00065
    Event Type
    Injury
    Date Received
    February 19, 1998
    Date of Event
    October 23, 1997
    Report Date
    November 11, 1997
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PLACEMENT ON 10/23/1997, THE GUIDEWIRE WAS RESISTANT & TORE CATHETER DURING REMOVAL. THE DAMAGED PORTION OF THE CATHETER WAS TRIMMED OFF. ONE WEEK LATER, THE PT COMPLAINED OF PAIN. THERE WAS REDNESS AND SWELLING AT THE INSERTION SITE. THE CATHETER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG 3 FR PICC Implant LONG TERM INTRAVASCULAR CATHETER DQO BARD ACCESS SYSTEMS 7715300 36CH0104

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Congenital Anomaly| R