BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2981522 · Received February 27, 2013

    Report

    Report Number
    1416980-2013-04850
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    February 4, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - EXACT DATE OF EVENT IS UNKNOWN.THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4):THIS REPORT IS A DUPLICATE OF REPORT NUMBER 1416980-2013-05740. ALL FURTHER REPORTING WILL BE ADDRESSED IN MANUFACTURER REPORT NUMBER 1416980-2013-05740.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONTINU-FLO SOLUTION SET HAS PARTICULATE MATTER INSIDE OF THE SET. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84302 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1