BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 6585917 · Received May 23, 2017

    Report

    Report Number
    1416980-2017-04435
    Event Type
    Malfunction
    Date Received
    May 23, 2017
    Report Date
    July 19, 2017
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SECOND COMPLAINT EVALUATION FOLLOW UP. THIS FOLLOW UP IS TO ADDRESS THE PRODUCT CODE 2H5660. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED (B)(4) AND AN EVALUATION IS COMPLETE. VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. FUNCTIONAL TEST WAS PERFORMED WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE BRAND NAME FOR 2N3350 IS MICRO-VOLUME EXTENSION SET; THE BRAND NAME FOR 2H5660 IS SOLUTION ADMINISTRATION SETS. CATALOG NUMBER - THE REPORTER INDICATED THAT THE INVOLVED PRODUCT CODE WAS EITHER 2N3350 OR 2H5660. MANUFACTURER - THE MANUFACTURING FACILITY FOR 2N3350 IS: (B)(4). THE MANUFACTURING FACILITY FOR 2H5660 IS: (B)(4). THE 510K NUMBER FOR 2N3350 IS K113227; THE 510K NUMBER FOR 2H5660 IS K153158. (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING SEPARATED FROM THE FILTER OF AN ADMINISTRATION SET, LEADING TO A LEAK. THIS WAS REPORTED TO HAVE OCCURRED EITHER DURING PRIMING OR DURING INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366212 NI SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1