BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS

    MDR report key: 3132903 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13495
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 1, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT FROM A CUSTOMER REGARDING AN UNSPECIFIED INFECTION IN A PATIENT OF THE NICU. THE EVENT WAS REPORTED TO HAVE OCCURRED WHILE A CONTINU-FLO SOLUTION SET WAS IN USE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234574 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other