BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO® CONNECTOR

    MDR report key: 22318604 · Received June 24, 2025

    Report

    Report Number
    9617594-2025-01323
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Date of Event
    May 1, 2025
    Report Date
    July 22, 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
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE DEVICE, IT IS NOT AVAILABLE FOR INVESTIGATION AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD IS PENDING. ADDITIONAL CONTACTS: (B)(4) POST MARKET SURVEILLANCE SPECIALIST, FRESENIUS MEDICAL CARE NORTH AMERICA, 920 WINTER STREET, WALTHAM, MA 02451. (B)(4). (B)(4). REGISTERED NURSE, 951 DUNBAR VILLAGE PLAZA STE A07 DUNBAR WV 25064 UNITED STATES, (B)(4).

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF TIP OF TEGO WAS TORN ON ITEM 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. THE DEVICE HISTORY REVIEW (DHR) LOT# WAS REVIEWED, AND NO NON-CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED CONDITION ON THE COMPLAINT. D9 - DEVICE AVAILABLE FOR EVALUATION: NO.

    Description of Event or Problem · 0

    THE REPORTER STATED THAT WHEN STARTING CATHETER CARE, THE NURSE NOTICED THE TIP OF TEGO WAS TORN. MULTIPLE ISSUES WITH TEARING WERE REPORTED, DESPITE REPEAT EDUCATION REGARDING NOT OVER TIGHTENING. THE DATE THAT THE EVENT OCCURRED WAS NOT REPORTED. A MEDWATCH VOLUNTARY REPORT #: MW5170996 WAS RECEIVED ON 13-JUN-2025, WHICH STATED ¿IT WAS REPORTED TO FRESENIUS MEDICAL CARE VIA EMAIL THAT WHEN STARTING CATHETER CARE, NURSE NOTICED TIP OF TEGO WAS TORN. WE ARE HAVING MULTIPLE ISSUES WITH TEARING, DESPITE REPEAT EDUCATION REGARDING NOT OVER TIGHTENING. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).¿ ADDITIONAL EVENT INFORMATION OBTAINED FROM UFMW: THE INITIAL REPORTER ASKED TO REMAIN CONFIDENTIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427469 TEGO® CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14265941 00840619026059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNSPECIFIED CATHETER, MFR UNK.