BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OKAY II

    MDR report key: 24921333 · Received April 19, 2026

    Report

    Report Number
    3007835716-2026-00046
    Event Type
    Malfunction
    Date Received
    April 19, 2026
    Date of Event
    December 18, 2025
    Manufacturer
    NIPRO VASCULAR CORPORATION
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS NOT BEEN COMPLETED YET; THEREFORE, THE CAUSE OF THIS EVENT HAS NOT BEEN DETERMINED. THIS IS AN INITIAL REPORT, AND THE RESULTS OF THE INVESTIGATION WILL BE DESCRIBED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR WAS DRAWN INTO THE PRODUCT DURING THE PROCEDURE. THE PRODUCT WAS REPLACED, AND THE PROCEDURE WAS CONTINUED. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982117 OKAY II Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass DTL NIPRO VASCULAR CORPORATION YOK0A YACC25H003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown