BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARD ACCESS SYSTEMS

    MDR report key: 331185 · Received May 7, 2001

    Report

    Report Number
    331185
    Event Type
    Death
    Date Received
    May 7, 2001
    Date of Event
    May 1, 2001
    Report Date
    May 1, 2001
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A PICC LINE INSERTED FOR LONG TERM ANTIBIOTICS THERAPY. WHILE THE PT'S GOWN WAS BEING CHANGED, THE PICC LINE BROKE. APPROXIMATELY 10 MINUTES LATER, THE PT DEVELOPED CHEST PAIN AND SOB. THE PT WENT ON TO STROKE AND EXPIRED APPROX. 7 HOURS LATER. THE PT WAS TO BE DISCHARGED TO REHAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20893 BARD ACCESS SYSTEMS GROSHONG CATHETER DQO BARD ACCESS SYSTEMS * 22KK4603

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death PICC LINE INSERTED 04/17/2001.