BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICC

    MDR report key: 716366 · Received May 15, 2006

    Report

    Report Number
    1720496-2006-00154
    Event Type
    Injury
    Date Received
    May 15, 2006
    Date of Event
    April 25, 2006
    Report Date
    May 1, 2006
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT STARTED TPN ON 04/20/2006 THROUGH EARLY 04/25/2006. TURNED OF TPN ON 04/25/2006 DUE TO THE PATIENT'S NECK SWELLING SLIGHTLY. THE PATIENT'S NECK WAS SWELLED PRIOR TO THE CT SCAN TAKING PLACE. THE DOCTOR ORDERED THE CT SCAN TO BE DONE QUICKLY. THE CT SCAN WAS DONE WITHOUT TIP VERIFICATION EVEN KNOWING THAT THE PATIENT'S NECK WAS SWELLING. THE CT SCAN CAUSED AN EXTRAVASATION IN THE PATIENT'S NECK, WHICH CAUSED SEVERE SWELLING. THE PATIENT WAS IN THE ICU WITH HIS NECK RETURNING TO NORMAL SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICC IMPLANTED LONG TERM INTRAVASCULAR DQO C.R. BARD, INC. (BASD) * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention