BEUDAMED
    FDA Adverse Event Summary report: N

    BD FIRST PICC

    MDR report key: 1614570 · Received February 5, 2010

    Report

    Report Number
    1614570
    Date Received
    February 5, 2010
    Date of Event
    January 2, 2010
    Report Date
    February 3, 2010
    Manufacturer
    BD MEDICAL SYSTEMS
    Product Code
    LJS
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NIGHT NURSE COMPLETED A HEEL STICK ON THE INFANT AND NOTED EDEMA ON THE INFANT'S CHEST AREA. UPON FURTHER REVIEW EDEMA NOTED ON BILATERAL CHEST AREA TO ABDOMEN WITH ECCHYMOSED AREA ON UPPER CENTER OF CHEST JUST LEFT OF MIDLINE. PICC INFUSION STOPPED AT THIS TIME AND PICC LINE REMOVED. APPROXIMATELY TWO HOURS LATER, THE DAYSHIFT RN MEASURED DARK RED/PURPLE AREA ON CHEST AT 3.5CM BY 2CM IN AN OBLONG SHAPE ACROSS UPPER LEFT CHEST WITH REDNESS NOTED RADIATING OUT FROM DEMARCATED LINE OF PURPLE AREA TO UNDER CHIN AND TO STERNUM. EDEMA NOTED ACROSS CHEST EXTENDING TO MIDAXILLARY LINE BILATERAL AND DOWN BEYOND STERNAL BORDER ON RIGHT SIDE TO LOWER ABDOMINAL QUADRANT. THE ENTIRE AREA SOFT, AND APPEARS NON-TENDER WHEN PALPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD FIRST PICC CATHETER, PICC LJS BD MEDICAL SYSTEMS * 8231654
    2 ABBOTT PLUM A PUMP, IV FRN HOSPIRA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO