BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2964187 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03974
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K964850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO NOT BE AVAILABLE FOR EVALUATION. SINCE THE LOT NUMBER OF THE DEVICE INVOLVED ARE UNKNOWN, A BATCH REVIEW CANNOT BE PERFORMED. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. IF THE SAMPLE IS RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED A BAXTER MEDICAL AFFAIRS SPECIALIST TO REPORT AN ISSUE WITH ONE INTERLINK EXT SET 2/.22 MICRONINJ. L/L/ ADAPTER DISPOSABLE SET. ACCORDING TO THE REPORT, THE NURSE WAS EXECUTING A PROCEDURE AND NOTICED AN UNKNOWN WHITE SOLUTION LEAKING FROM THE FILTER. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR ADVERSE EVENT IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68892 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1