BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAF-T HOLDER

    MDR report key: 2222836 · Received August 16, 2011

    Report

    Report Number
    2222836
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    SMITHS MEDICAL ASD
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SAF-T HOLDER DEVICE WAS ATTACHED TO THE IV EXTENSION TUBING AND BLOOD TUBES WERE CONNECTED TO DRAW LABS. WHEN THE BLOOD TUBES WERE REMOVED, THE DEVICE CONTINUED TO LEAK BLOOD. IT APPEARED AS THOUGH THE RUBBER OVER THE NEEDLE WAS PUNCTURED AND THE NEEDLE WAS EXPOSED. THIS IS THE FOURTH INCIDENT OF THIS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAF-T HOLDER BLOOD COLLECTION SYSTEM JKA SMITHS MEDICAL ASD * 1815788
    2 EXTENSION SET WITH ULTRASITE INJECTION SITE AND SPIN-LOCK CC INTRAVASCULAR TUBING, EXTENSION SET FPA B BRAUN US1320 0061157069

    Patients

    Seq Age Sex Outcome Treatment
    1 *