BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO¿ CONNECTOR

    MDR report key: 21114145 · Received January 9, 2025

    Report

    Report Number
    9617594-2025-00041
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 6, 2024
    Report Date
    March 31, 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
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D9 - DEVICE AVAILABLE FOR EVALUATION: NO A DHR LOT AND RELEVANT COMMODITIES WERE REVIEWED, THE FOLLOWING DISCREPANCY WAS IDENTIFIED: EXCEPTION TYPE: NCMR DOCUMENT ID#: (B)(6) LOT#: 13938363, 13899644, 13765767 DISCREPANCIES: "G8 AND H1-H8 HAVE WINDOW OCCLUSION. AFTER PERFORMING FUNCTIONAL TEST TM 0000090 THE WINDOW AREA STILL OCCLUDED AND THE RIB IS UNDER SILICONE PART. TOTES1-4 WERE AFFECTED." TRANSLATION "THAT? MANUFACTURING REPORTS COMPONENT R1-3701 LOT 13765767 WITH THE HOLE COVERED, WHERE THE HOUSING NOTCH GOES WHEN ASSEMBLED, IN ORDER 13938363 ITEM D1000. " "THAT? 3 PIECES PART NUMBER R1-3701 REV.19 LOT# 13765767 WERE REPORTED WITH "WINDOW OCCLUDED AND/OR SHORT SHOT. WHEN? 03-22-2024 WHERE? DURING THE MANUFACTURING PROCESS, AQL 0.25 C =0 WHO? MANUFACTURING LEADER CR1 1ST SHIFT QUANTITY IMPACTED AND RESULTS OF THE SAMPLING (FAIL/PASS): 26,819 PIECES, AFFECTED FAILURE: 3/135." "EGO SEAL WITH OCCLUDED WINDOW COVERING THE RIB FROM THE TEGO BODY" HNGUYEN (B)(6) 2025.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A SUDDEN TOTAL BLOCK IN FLOW WITH TWO TEGO¿ CONNECTORS AT THE START OF DIALYSIS TREATMENT. THE ISSUE WAS RESOLVED AFTER CHANGING THE TEGO WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WERE NO CUTS, HOLES OR DEFECTS NOTED ON THE TEGO DEVICE. THERE WAS NO SERIOUS INJURY OR DEATH, NO CLINICALLY SIGNIFICANT BLOOD LOSS, AND NO PROPERTY DAMAGE. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED OTHER THAN ROUTINE CHANGE OR MAINTENANCE. THIS REPORT REFLECTS SECOND OF TWO OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352581 TEGO¿ CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13938363 00840619026059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown