BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2220820 · Received August 23, 2011

    Report

    Report Number
    6000001-2011-20414
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DID NOT RETURN A SAMPLE FOR EVALUATION. THE SET IS UNKNOWN AND THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. THE DEVICE USED IN THIS SITUATION IS UNKNOWN; THEREFORE, A US 510K NUMBER CANNOT BE PROVIDED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED TO BAXTER AN INCIDENT IN WHICH "BLOOD HAD BACKED UP INTO THE LINE" OF AN UNKNOWN IV SET ON AN UNKNOWN DATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. SAMPLE AVAILABILITY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1