BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET WITH ULTRASITE INJECTION AND SPIN-LOCK CONNECT

    MDR report key: 2222792 · Received August 16, 2011

    Report

    Report Number
    2222792
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    B BRAUN
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN IV START AND BLOOD DRAW, THE LUER CLOSEST TO THE PATIENT LEAKED BLOOD. DISCARDED AND NEW DEVICE USED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *