BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4862313 · Received June 23, 2015

    Report

    Report Number
    1416980-2015-26260
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    April 22, 2015
    Report Date
    June 2, 2015
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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 WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LINE OF A CONTINU FLO SET WAS MELTED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405245 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 14L22V924

    Patients

    Seq Age Sex Outcome Treatment
    1