BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM

    MDR report key: 222183 · Received May 5, 1999

    Report

    Report Number
    MW1016259
    Event Type
    Injury
    Date Received
    May 5, 1999
    Date of Event
    May 3, 1999
    Report Date
    May 5, 1999
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT USED BECTON DICKINSON ATRIUM ON HER CENTRAL VENOUS CATHETER. AFTER TPN INFUSION WITH LIPIDS, PT REMOVED LUER LOCK OF PRIMARY LINE, AND PLUNGER THAT IS DEPRESSED BY MALE LUER "STUCK" AND WAS SUPPOSED TO POP BACK UP. THIS LEAD TO BLEEDING FROM THE END OF THE ATRIUM. PT SHIPPED DEVICE BACK TO PHARMACY IN A BIOHAZARD SAFE BAG, WHERE STAFF VISUALIZED THE DEPRESSED PLUNGER WITH DRIED BLOOD AROUND THE OPENING. PT BLEEDING STOPPED WITH APPLICATION OF NEW CAP, BUT PROBLEMS COULD HAVE BEEN WORSE WITH THIS BEING AN OPEN CENTRAL LINE. PT GIVEN ATRIUM EXTENSION SETS, WITH A CLAMP ON IT TO ENSURE NO BACK FLOW. PT LIVES BY HERSELF AND CARES FOR LINE COMPLETELY INDEPENDENTLY. THIS OCCURRED IN APRIL, AND ON 5/4 ALSO. PT THREW AWAY VALVES (ATRIUM). PT NOW USING THREADED LOCK CANNULA AND INTERLINK CAP; HAD IN PAST UNTIL EDUCATED BY HOME HEALTH ON HOW TO USE EXTENSION. CO SENDING DIFFERENT LOT # BATCH OF ATRIUM MASTER ADAPTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRIUM END CAP FOR LINES, IV ACCESS SYSTEM FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. * 810408

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention