BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR OPVSU SI NPS

    MDR report key: 19285083 · Received May 10, 2024

    Report

    Report Number
    1518293-2024-00011
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    April 11, 2024
    Report Date
    May 10, 2024
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    UDI-DI
    10746190002901
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS CASE WAS REPORTED BY A FACILITY IN (B)(6) ON 11 APIRL 2024. REPORTER STATES THAT LFI OPTIVANTAGE INJECTOR PRESSURE WAS OUT OF SPEC, GOING HIGHER THAN NORMA, WITH NO ERROR CODES BEING DISPLAYEDL. THIS EVENT OCCURRED DURING A PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH POTENTIAL HARM TO THE PATIENT, IN THE FORM OF INFILTRATION/EXTRAVASATION. IN A FOLLOW-UP, THE REPORTER STATED THAT THERE WAS NO CLINICAL CONSEQUENCE OF THE INFLITRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039545 INJECTOR OPVSU SI NPS INJECTOR OPVSU SI NPS IZQ LIEBEL-FLARSHEIM 849001 10746190002901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown