BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2832442 · Received November 14, 2012

    Report

    Report Number
    1416980-2012-05169
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 26, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FMG
    PMA / PMN Number
    K932512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - EVALUATION IS PENDING RECEIPT OF THE SAMPLE. UPON COMPLETION OF THE EVALUATION, OR SHOULD ANY ADDITIONAL INFORMATION BE MADE AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4) - THE REPORTED CONDITION OF ONE CLEARLINK CONTINU-FLO ADMINISTRATION SET THAT WAS ALLEGED TO HAVE A LOOSE CONNECTION ON THE UPSTREAM LUER CLOSEST TO THE MANIFOLD WAS NOT CONFIRMED DURING PRODUCT EVALUATION; THEREFORE, NO ROOT CAUSE COULD BE ASSIGNED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A LABELING REVIEW WAS PERFORMED, FINDING THE LABELING ACCURATE AND SUFFICIENT. SHOULD ANY ADDITIONAL INFORMATION BE MADE AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO A BAXTER REPRESENTATIVE A CONDITION OF ONE CLEARLINK CONTINU-FLO ADMINISTRATION SET THAT WAS ALLEGED TO HAVE A LOOSE CONNECTION ON THE UPSTREAM LUER CLOSEST TO THE MANIFOLD. THIS LUER WAS OBSERVED LOOSE BEFORE USE, AND WAS TIGHTENED BY THE FACILITY, BUT AGAIN CAME LOOSE DURING INFUSION ON AN UNKNOWN PATIENT. IT IS UNKNOWN WHAT SOLUTION WAS BEING INFUSED. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - AIBONITO UR12F19060

    Patients

    Seq Age Sex Outcome Treatment
    1