BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO® CONNECTOR

    MDR report key: 21767318 · Received April 3, 2025

    Report

    Report Number
    9617594-2025-00637
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    August 1, 2024
    Report Date
    April 3, 2025
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED EIGHTEEN (18) USED. LIST #D1000, TEGO¿ CONNECTOR, APPX 0.05 ML; LOT #1 3854649. SAMPLE # 14 (THIS IS THE FOURTH OF 5 THAT WERE FOUND DAMAGED). THE PROBABLE CAUSE OF THE TOP SILICONE SEAL DAMAGE IS DUE TO VARIATION ON TEGO SEAL MATERIAL WHICH HAS A DIRECT IMPACT ON FUNCTIONAL PERFORMANCE OF THE TEGO CONNECTOR WITH AN ADDITIONAL CONTRIBUTING FACTOR REGARDING UNEVEN ADHESIVE APPLICATION. A DEVICE HISTORY REPORT (DHR) LOT # AND RELEVANT COMMODITIES WERE REVIEWED, THE FOLLOWING DISCREPANCY WAS IDENTIFIED: EXCEPTION TYPE: NCMR DOCUMENT ID #: (B)(4). LOT #: 13763983 DISCREPANCY: "DURING FA2 INSPECTION ON 10/5/2023 SHIFT B2 FOR PRESS8 ITEM R1-3701(TEGO SEAL , ONE SHOT); MOLDING QA FOUND CAVITY Y8 HAS DAMAGE AT DIMENSION 0.266 LOCATION ON DRAWING C-6. AFTER BRACKETING TOTES 22-23 WERE AFFECTED. ADDING TOTES 24-28(TOTE28 IS A PARTIAL QTY (B)(4); ON 10/9/2023 DIMENSIONAL QA SHIFT B1 FOUND CAVITIES Y2;Y4;Y5 AND Y7 FAILED DIMENSION 0.002 +0.004/-0.002, MEASURED AT 0.0065 TO 0.0075 MAX ALLOWED IS 0.006. CAVITIES Y4 AND Y7 ALSO HAVE A BURR.ADDING TOTES 56-58 ; ON 11/24/2023 MOLDING QA FOUND CAVITY Y3 FAILED MEMBRANE THICKNESS MEASURED AT 0.008 MAX ALLOWED IS 0.006." A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) PLAN HAS BEEN IMPLEMENTED TO ADDRESS THE IDENTIFIED ISSUE. THE OUTCOME OF THE CAPA IS CURRENTLY UNDER EVALUATION AND IS NOT YET FINALIZED.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A TEGO® CONNECTOR. IT WAS REPORTED THAT THERE WERE TEGO ISSUES WHEN THEY ARE DOING THEIR ANALYSIS. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND UNKNOWN HUMAN HARM. EIGHTEEN (18) DEVICES USED WERE RECEIVED FOR INVESTIGATION. FIVE (5) FOUND TO HAVE SILICONE SEAL DAMAGES. THIS CAPTURES THE FOURTH OF 5. SEE SECTION H11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575360 TEGO® CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13854649 00840619026059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown