BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MD - DISPOSABLE

    MDR report key: 1961895 · Received January 14, 2011

    Report

    Report Number
    6000001-2011-00285
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 16, 2010
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER OF THIS DEVICE IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. THE DEVICE USED IN THIS SITUATION IS UNKNOWN; THEREFORE, A 510K NUMBER CANNOT BE PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE AN UNKNOWN SET THAT WOULD NOT INFUSE AT ALL. IT IS UNKNOWN IF THIS ISSUE OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MD - DISPOSABLE SET, ADMINISTRATION, INTRAVASCULAR FPA

    Patients

    Seq Age Sex Outcome Treatment
    1