BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D-300 IV ADMINISTRATION SET

    MDR report key: 730165 · Received May 24, 2006

    Report

    Report Number
    1221261-2006-00014
    Event Type
    Malfunction
    Date Received
    May 24, 2006
    Report Date
    May 24, 2006
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    H.6 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 THEN WHAT IS REPORTED; THAN A FOLLOW UP REPORT WILL BE FILED. A REVIEW OF OUR COMPLAINTS DATABASE SHOW NO OTHER REPORTS ON THIS LOT NUMBER OR ANY OTHER LOT NUMBER FOR A SIMILAR ISSUE. THIS REPORT WAS FORWARDED TO OUR CURRENT MANUFACTURER FOR REVIEW AND THERE WAS NO TRENDING HISTORY WITH RESPECT TO THIS DISCREPANCY. HOWEVER THE MOST PROBABLE ROOT CAUSE IS IF THE 3 PSI LEAK TEST DID NOT DETECT THE LEAK IN THE INSERT. CONCLUSION: AS A RESULT OF THIS COMPLAINT, ALL PERSONNEL INVOLVED WERE RETRAINED BY THE PRODUCTION MANAGER AND SUPERVISOR ON MAY 29, 2006. IN ADDITION, A CORRECTIVE ACTION REQUEST HAS BEEN ASSIGNED TO EVALUATE THE EFFECTIVENESS OF THE LEAK TEST PROCEDUR AND WILL BE MANAGED THROUGH THE CORRECTIVE AND PREVENTIVE ACTION SYSTEM.

    Description of Event or Problem · 1

    USER ALLEGES THAT THE BLUE CAP ON THE PATIENT LINE WHERE MEDICINES ARE ADMITTED BLEW OFF AND BLOOD SQUIRED AROUND THE ROOM HITTING THE PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D-300 IV ADMINISTRATION SET IV ADMINISTRATION SET FPA SMITHS MEDICAL ASD, INC. D-300 740990

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO