BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD THREADED LOCK CANNULA

    MDR report key: 17777 · Received October 13, 1994

    Report

    Report Number
    17777
    Event Type
    Death
    Date Received
    October 13, 1994
    Date of Event
    October 4, 1994
    Report Date
    October 12, 1994
    Manufacturer
    BECTON DICKINSON & CO.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE RECENTLY HAVE BEEN THREE REPORTED INCIDENTS OF AN EXTENSION TUBING BECOMING DISCONNECTED FROM A THREADED-LOCK CANNULA. THE FIRST INSTANCE ON TUESDAY/WEDNESDAY, 10/4/94 RESULTED IN A PT'S DEATH. THE OTHER TWO INSTANCES DID NOT RESULT IN PT-RELATED PROBLEMS. THE SECOND WAS ON 10/6/94 AND THE THIRD WAS OVER THE WEEKEND OF 10/8-9/94. THE LIP ON THE CONNECTOR DOES NOT APPEAR TO SECURELY ENGAGE THE RIDGES ON THE LUER LOCK. EVEN WHEN THE CONNECTION SEEMS SECURE AND DOES NOT LEAK, IT CAN SUBSEQUENTLY DISCONNECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD THREADED LOCK CANNULA CANNULA FPA BECTON DICKINSON & CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 MO Death