BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO® CONNECTOR

    MDR report key: 9158052 · Received October 4, 2019

    Report

    Report Number
    9617594-2019-00329
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    September 5, 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 ¿ ONE USED D1000 TEGO WAS RECEIVED FOR INVESTIGATION ON 10/4/2019. THE USED D1000 TEGO WAS VACUUM AND PRESSURE LEAK TESTED. A SMALL TEAR AT THE END OF THE SLIT ON THE TOP SURFACE OF THE SEAL WAS CONFIRMED TO BE THE THE SOURCE OF THE LEAKAGE. NO MATING DEVICES WERE RETURNED TO EVALUATE WITH THE USED D1000 TEGO. THE PROBABLE CAUSE OF THE SMALL TEAR AT THE END OF THE SLIT ON THE TOP SURFACE OF THE TEGO SEAL THAT RESULTED IN LEAKAGE CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE EVENT INVOLVED A TEGO CONNECTOR THAT DURING A DIALYSIS SESSION, TEN MINUTES AFTER THE CANAUD CATHETER WAS CONNECTED AND THE TEGO® CONNECTOR WAS CHANGED, THE AIR DETECTOR ALARM ACTIVATED. THE NURSE NOTED THE PRESENCE OF AIR BUBBLES IN THE ARTERIAL LINE. THE DEVICE WAS CHANGED OUT/ REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS NO ADVERSE EVENT OR DELAY IN CRITICAL THERAPY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951050 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 CANAUD CATHETER, MFR UNK.