BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO® CONNECTOR

    MDR report key: 9158063 · Received October 4, 2019

    Report

    Report Number
    9617594-2019-00330
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    September 4, 2019
    Report Date
    September 13, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619026059
    PMA / PMN Number
    K053106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H10 - THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE REPORTED COMPLAINT CANNOT BE CONFIRMED WITHOUT THE RETURNED SAMPLE. A DEVICE HISTORY REVIEW (DHR) LOT# 4032904 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION CAN BE FOUND IN SECTION B3 AND D10.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO RETURN FOR EVALUATION. IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A TEGO CONNECTOR THAT AT THE END OF THE DIALYSIS SESSION, THE NURSE DISCONNECTED THE ARTERIAL LINE FROM THE ARTERIAL BRANCH OF THE CATHETER AND THEN TOOK A STERILE 2ML SYRINGE TO CONTROL BLOOD SUGAR. AIR WAS NOTED COMING INTO THE SYRINGE BEFORE THE BLOOD. SHE ASPIRATED THE AIR AND CLAMPED THE LINE BEFORE PERFORMING NEW MANIPULATIONS. THE TEGO CONNECTOR WAS THEN REPLACED, NOTING NO AIR IN THE CATHETER AND GOOD BLOOD FLOW. THE NURSE AGAIN ASPIRES TO CHECK THE PERMEABILITY, FLUSHED THE LINE AND INSTALLED THE CONNECTOR. THERE WAS NO ADVERSE EVENT OR DELAY IN CRITICAL THERAPY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951062 TEGO® CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4032904 00840619026059

    Patients

    Seq Age Sex Outcome Treatment
    1