BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2872048 · Received December 13, 2012

    Report

    Report Number
    1416980-2012-07216
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FMG
    PMA / PMN Number
    K962581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE SAMPLE IS NOT AVAILABLE SO THE ROOT CAUSE CANNOT BE DETERMINED. NO CONCLUSION CAN BE DRAWN FROM THE INVESTIGATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER HEALTHCARE AN UNKNOWN QUANTITY OF THREE GANG 4-WAY LARGE BORE STOPCOCK MANIFOLD(S) IN WHICH UNSPECIFIED LEAKING WAS DETECTED. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1