BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 6388012 · Received March 8, 2017

    Report

    Report Number
    1416980-2017-01981
    Event Type
    Malfunction
    Date Received
    March 8, 2017
    Report Date
    April 25, 2017
    Manufacturer
    NI
    Product Code
    FPA
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER: WAS REPORTED AS EITHER 7N8399 OR 7N8377. BRAND NAME FOR 7N8399 IS ONE-LINK NEUTRAL LUER ACTIVATED DEVICE AND 7N8377 IS EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR. THE 510K NUMBER FOR BOTH POTENTIAL PRODUCT CODES IS K132734. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAPS SPONTANEOUSLY FELL OFF THE PORTS AND CONNECTORS OF A ONE-LINK DEVICE. THE REPORTER STATED THAT THIS CAUSED BLOOD TO POUR OUT OF THE PORT. 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
    169872 NI SET, ADMINISTRATION, INTRAVASCULAR FPA NI NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1