BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2833802 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05247
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER. EIGHT COMPANION SAMPLES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT REVEAL ANY NON-CONFORMITIES. A PUSH PULL TEST ON THE EIGHT SAMPLES WAS PERFORMED BETWEEN TUBE AND LUER LOCK WITH NO ISSUES NOTED. THE EVALUATION DID NOT CONFIRM THE REPORTED PROBLEM AND, THEREFORE, AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS WERE NOTED.

    Description of Event or Problem · 1

    THE FACILITY CONTACTED BAXTER (B)(4) TO REPORT A FLOGARD 6201G COMPATIBLE BLOOD SET THAT "THE PATIENT END CONNECTOR IS NOT FITTED CORRECTLY". THIS MALFUNCTION OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT, NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - MALTA 12F19V955

    Patients

    Seq Age Sex Outcome Treatment
    1