BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO CONNECTOR

    MDR report key: 10734493 · Received October 26, 2020

    Report

    Report Number
    9617594-2020-00457
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    August 15, 2020
    Report Date
    October 2, 2020
    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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: RECEIVED: ONE (1) USED LIST# D1000, TEGO¿ CONNECTOR. LOT# 4052480.-->ONE (1) USED CONNECTOR, UNKNOWN MANUFACTURER. A USED D1000 TEGO CONNECTOR WAS RETURNED CONNECTED AT THE MALE LUER END TO AN UNIDENTIFIED FEMALE LUER ADAPTER. THERE WERE NO VISIBLE DAMAGE OR ANOMALIES OBSERVED WITH THE D1000 TEGO CONNECTOR OR MATING DEVICE. SUBSEQUENT FUNCTIONAL TESTING SHOWED THE D1000 TEGO CONNECTOR (WITH MATING DEVICE) TO MEET FUNCTIONAL LEAK EXPECTATIONS OUTLINED IN THE PRODUCT PERFORMANCE SPECIFICATION. THE COMPLAINT OF LEAKAGE WAS UNABLE TO BE CONFIRMED. A DEVICE HISTORY REVIEW (DHR) LOT# 4052480 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A TEGO CONNECTOR THAT THE CUSTOMER REPORTED BLOOD LEAKING OUT OF THE CAP DURING TREATMENT. THE RN NOTED THERE WAS NO TEAR/CRACK EVIDENT WITH VISUAL INSPECTION, HOWEVER, IT WAS NOTED THAT SEPTUM WAS BROKEN/TORN WHEN THE RN TRIED TO ATTACH BLUE TUBE AND FLUSHED THE TEGO CAP DURING INVESTIGATION. THE CUSTOMER STATED IT WAS NOT DETECTED PRIOR TO USE. THERE WAS 10 ML OF BLOOD LOSS, NO PROPERTY DAMAGE, AND A MEDICAL, OR SURGICAL INTERVENTION WAS REQUIRED. THE MEDICAL INTERVENTION REQUIRED WAS THE PATIENT REQUIRING BLOOD CULTURES, AND INITIATION OF IV ANTIBIOTICS DUE TO POSSIBLE LINE CONTAMINATION, AND THE PATIENT ALSO REQUIRED HOSPITALIZATION FOR MONITORING. THE CURRENT PATIENT STATUS WAS RETURNED TO BASELINE AFTER THE INCIDENT. IT WAS ALSO MENTIONED THAT THE DEVICE WAS REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS PATIENT INVOLVEMENT, BUT NO SERIOUS INJURY, OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199370 TEGO CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4052480 00840619026059

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSP DIALYSIS LINE, MFR UNK| UNSP DIALYSIS LINE, MFR UNK