BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DI-50 IV ADMINISTRATION SET

    MDR report key: 5305935 · Received September 14, 2004

    Report

    Report Number
    1221261-2004-00032
    Event Type
    Malfunction
    Date Received
    September 14, 2004
    Report Date
    August 17, 2004
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL ASD, INC. IS ANTICIPATING THE RECEIPT OF THE SAMPLE INVOLVED IN THIS EVENT. UPON RECEIPT OF TH SAMPLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    USER ALLEGES THAT BLOOD FROM THE DI-50 SET LEAKED INTO THE H-1025. SMITH S MEDICAL ASD, INC. COMPLAINT NO. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DI-50 IV ADMINISTRATION SET IV ADMINISTRATION SET FPA SMITHS MEDICAL ASD, INC. DI--50 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI