BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4090891 · Received September 15, 2014

    Report

    Report Number
    1416980-2014-31397
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    August 21, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K132734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ONE-LINK CONNECTOR WAS DIFFICULT TO FLUSH. IT IS UNKNOWN WHEN THIS OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568436 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1