BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OKAY II

    MDR report key: 19790259 · Received July 22, 2024

    Report

    Report Number
    3007835716-2024-00230
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    July 4, 2024
    Manufacturer
    GOODMAN CO., LTD.
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, AND THE INVESTIGATION WAS UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED PROBLEM. THE REPORTED EVENT MAY HAVE BEEN CAUSED BY LEAKAGE FROM THE HEMOSTASIS VALVE, DUE TO THE INFLUENCE OF THE ANGLE OF THE COMBINED DEVICE INSERTED INTO THE PRODUCT OR DUE TO THE OPENER WAS OPENED BY MISTAKE, BUT THE DETAILED CAUSE COULD NOT BE IDENTIFIED. THE Y-CONNECTOR IS ATTACHED TO A DEVICE SUCH AS A GUIDING CATHETER FOR THE PURPOSES OF REDUCING BLOOD LEAKAGE AND FOR FIXATION OF DEVICES INSERTED INTO THE VASCULATURE. THE HEMOSTATIC VALVE IS DESIGNED TO FACILITATE CATHETER DELIVERY, AND WILL NOT COMPLETELY ELIMINATE BLOOD LOSS, CONDITIONS OF USE WILL DETERMINE VOLUME OF BLOOD LOSS. LEAKAGE OF BLOOD WHEN THE HEMOSTASIS VALVE IS OPEN OR THE DEVICE IS INSERTED DOES NOT INDICATE A MALFUNCTION OF THE PRODUCT. THE INSTRUCTIONS FOR USE (IFU) PROVIDE GENERAL INSTRUCTIONS FOR USE, WARNINGS AND PRECAUTIONS RELATED TO THE DEVICE, AND INFORMATION TO MAKE YOU AWARE OF POTENTIAL COMPLICATIONS AND OTHER EVENTS SIMILAR TO THIS EVENT THAT MAY OCCUR. THIS REPORT DOES NOT IMPLY AN ADMISSION BY ANYONE THAT THE PRODUCTS MENTIONED IN THIS REPORT ARE DEFECTIVE. HOWEVER, SINCE WE HAVE NOT BEEN ABLE TO CONFIRM THE ACTUAL PRODUCT, WE CANNOT DENY THAT THE BLOOD LEAKAGE OCCURRED BECAUSE THE PRODUCT WAS DAMAGED, SO WE ARE SUBMITTING THIS REPORT CONSERVATIVELY.

    Description of Event or Problem · 0

    BLOOD LEAKED FROM THE HEMOSTASIS VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737369 OKAY II Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass DTL GOODMAN CO., LTD. YOK0A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose