BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS ACACIA

    MDR report key: 1061848 · Received June 13, 2008

    Report

    Report Number
    MW5007321
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 13, 2008
    Manufacturer
    MPS ACACIA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING CT SCAN CORRELATION FOR RADIATION PLANNING; EXTENSION SET TO PRN LOCK SPLIT AT THE START OF INJECTION OF CONTRAST. SET UNCLAMPED, CAUSING CONTRAST TO LEAK ON PT; CT HALTED AND STUDY COMPLETED WITHOUT USE OF CONTRAST. PATIENT UPSET WITH THIS EVENT BUT NO PHYSICAL HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MPS ACACIA EXTENSION TUBING FPA MPS ACACIA 385150 A0423

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR