BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3071263 · Received April 22, 2013

    Report

    Report Number
    1416980-2013-10011
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 29, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SETS SPIKE WAS BROKEN OFF AT THE DRIP CHAMBER. THIS MALFUNCTION WAS IDENTIFIED WHEN THE SET WAS REMOVED FROM THE CASE BEFORE USE. THE SPIKE'S PROTECTIVE CAP WAS INTACT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171868 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R12K14088

    Patients

    Seq Age Sex Outcome Treatment
    1