BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 5900532 · Received August 24, 2016

    Report

    Report Number
    1416980-2016-14515
    Event Type
    Malfunction
    Date Received
    August 24, 2016
    Report Date
    August 24, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER - THE DEVICE WAS REPORTED TO HAVE ONE OF THE THREE PRODUCT CODES: 2C8537, 7N8399, OR 7N8301. (B)(6). THE 2C8537 HAS A 510(K) NUMBER OF K961225; 7N8399 AND 7N8301 HAVE A 510(K) NUMBER OF K132734. 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 SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKED FROM THE CONNECTION OF AN ADMINISTRATION SET TO THE PATIENT'S CATHETER. THIS OCCURRED WHILE ATTEMPTING TO CONNECT THE SET TO THE CATHETER. THERE WAS NO REPORT OF 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
    553531 NI SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1