BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4100257 · Received September 18, 2014

    Report

    Report Number
    1416980-2014-32108
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RECEIVED FOR EVALUATION. THE DEVICE WAS CONNECTED TO AN IN-HOUSE SOLUTION BAG AND PRIMED AND A LEAK WAS OBSERVED FROM THE TOP Y-SITE. DURING VISUAL INSPECTION THE Y-SITE A BROKEN LUER WAS OBSERVED STUCK IN THE GLAND. THE BROKEN LUER WAS REMOVED FROM THE GLAND AND THE DEVICE WAS FUNCTIONALLY TESTED AGAIN WITH NO DEFECTS NOTED. A COMPANION SAMPLE WAS RETURNED AND ALSO UNDERWENT THE SAME EVALUATION WITH NO DEFECTS NOTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VALVE ON THE UPPER-Y-SITE OF A CLEARLINK SET DID NOT RE-SEAL AND SALINE FLOWED OUT ON THE FLOOR WHEN THE SECONDARY MEDICATION SET WAS DISCONNECTED AND RECONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580248 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R14E05119

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SECONDARY SET