BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-100 IV ADMINISTRATION SET

    MDR report key: 725262 · Received June 13, 2006

    Report

    Report Number
    1221261-2006-00013
    Event Type
    Malfunction
    Date Received
    June 13, 2006
    Report Date
    May 22, 2006
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    H6. EVALUATION-OTHER: SMITHS MEDICAL ASD, INC. IS UNABLE TO PERFORM A THOROUGH INVESTIGATION WITHOUT THE RETURN OF THE ACTUAL SAMPLE INVOLVED. IF THE DISPOSABLE UNIT IS RETURNED AN INVESTIGATION WILL BE PERFORMED OR IF INFORMATION IS RECEIVED OTHER THAN WHAT IS REPORTED; THAN A FOLLOW-UP WILL BE FILED. A REVIEW OF MANUFACTURING RECORDS, FOR THIS DEVICE LOT NUMBER, HAD NO PROBLEMS THAT WOULD PROVIDE EXPLANTATION FOR THIS EVENT.

    Description of Event or Problem · 1

    USER ALLEGES THAT THEY HAD TWO SETS THAT BECAME DISCONNECTED DURING A PROCEDURE RESULTING IN BLOOD LEAKING ON TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-100 IV ADMINISTRATION SET IV ADMINISTRATION SET FPA SMITHS MEDICAL ASD, INC. D-100 200602EM

    Patients

    Seq Age Sex Outcome Treatment
    1 YR