BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DI-50 IV ADMINISTRATION SET

    MDR report key: 794793 · Received December 14, 2004

    Report

    Report Number
    1221261-2004-00038
    Event Type
    Malfunction
    Date Received
    December 14, 2004
    Date of Event
    November 10, 2004
    Report Date
    November 16, 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

    EVALUATION: SMITHS MEDICAL ASD, INC. IS ANTICIPATING THE RECEIPT OF THE SAMPLE, FROM THE SAME LOT, FROM THIS HOSPITAL. THEY DISPOSED OF THE ACTUAL EVENT SAMPLE. UPON RECEIPT OF THE LOT SPECIFIC 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 WATER TANK. NO PATIENT INJURY REPORTED.

    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 200312A

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO LEVEL 1 FLUID WARMER.