BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO¿ CONNECTOR

    MDR report key: 22948649 · Received September 2, 2025

    Report

    Report Number
    9617594-2025-01786
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    June 4, 2025
    Report Date
    September 2, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619030247
    PMA / PMN Number
    K053106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF NO FLOW / CAN'T PRIME / DIFFICULT TO PRIME ON ITEM 055-D1000 CANNOT BE CONFIRMED. SINCE NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND PROBABLE CAUSE CANNOT BE DETERMINED. LOT HISTORY REVIEW WAS CONDUCTED AND NO NON-CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED CONDITION ON THE COMPLAINT. ADDITIONAL CONTACT INFORMATION - DISTRIBUTOR: MEDCORP SAÚDE E TECNOLOGIA LTDA (B)(4). RUA ARMINDA 93 - 3º ANDAR, VILA OLIMPIA, SÃO PAULO, [email protected], +011(551)138498992.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A TEGO¿ CONNECTOR WHERE THE CUSTOMER REPORTED THAT AT THE INITIATION OF DIALYSIS, THE TEGO CONNECTOR PRESENTED AN OBSTRUCTION, WITH NO BLOOD RETURN AND RESISTANCE TO INFUSION. UPON REMOVAL OF THE CONNECTOR AND TESTING OF THE CATHETER, IT SHOWED GOOD FLOW. THE TEGO WAS THEN REPLACED, AND DIALYSIS WAS RESUMED WITH A BLOOD FLOW RATE (BFR) OF 350 ML/H, AS PER MEDICAL PRESCRIPTION. THIS ISSUE HAD BEEN LEADING TO THE NEED FOR TEGO REPLACEMENT BEFORE 7 DAYS. IT WAS ALSO REPORTED THAT THE CONNECTOR WAS PLACED ON (B)(6) 2025 AND THE ISSUE WAS NOTED 04-JUN-2025. THE CUSTOMER FURTHER STATED THAT THE TEGO PRESENTED OBSTRUCTION, WITH SIGNS OF RUPTURE SUCH AS NO BLOOD RETURN AND RESISTANCE TO INFUSION. THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474013 TEGO¿ CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14144999 00840619030247

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown