BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2964199 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03975
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    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 PRODUCT CODE AND LOT NUMBER OF THE DEVICE INVOLVED ARE UNKNOWN, A 510K NUMBER CANNOT BE PROVIDED AND A BATCH REVIEW CANNOT BE PERFORMED. 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 AN UNKNOWN PRIMARY DISPOSABLE SET. ACCORDING TO THE REPORT, THE NURSE WAS EXECUTING A PROCEDURE AND FELT RESISTANCE/DIFFICULTY WHEN INJECTING THE DRUG PROPOFOL. EVENTUALLY, THE PROPOFOL WAS SUCCESSFULLY INJECTED INTO THE PATIENT USING THE UPPER Y-SITE. 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
    68896 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1