BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO® CONNECTOR

    MDR report key: 18477161 · Received January 9, 2024

    Report

    Report Number
    9617594-2024-00016
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    October 30, 2023
    Report Date
    January 9, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    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

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE RETURN OF THE DEVICE A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A TEGO® CONNECTOR. IT WAS REPORTED THAT IN-CENTER HEMODIALYSIS PATIENT WHO HAS HAD A CHANGE IN THEIR CONNECTORS. BLOOD LEAK. BLOOD LOSS. DEVICE REPLACEMENT. MEDICATION REQUIRED. HEALTH CANADA LRN-20231207-573, REF.# 1074126, HEALTH CANADA DEVICE ID: (B)(4). HEALTH CA RCT# RCT-20231207-563. THERE WAS A PATIENT INVOLVED, AND LOSS OF BLOOD, AND MEDICATION REQUIRED. STAFF WAS MADE AWARE OF THE PROBLEM BY AN EMPLOYEE WHO LEFT A NOTE THAT HE HAD A PROBLEM WITH A TEGO CAP IN SUCH A PATIENT. PATIENT CALLED IN THE EVENING (AROUND 7:10 P.M.) ON 30 OCTOBER 2023, THE SAME DAY OF HIS DIALYSIS TREATMENT, THAT HE HAS A BLOOD STAIN ON HIS SHIRT FROM THE DIALYSIS CATHETER. THE SPOUSE INFORMED THEM THAT THE BLEEDING IN SMALL, SLOW DROPS CAME FROM THE TEGO CONNECTOR OF THE RED CHANNEL DESPITE THE CLAMPING PRESS. PATIENT CAME TO THE HOSPITAL FOR INVESTIGATION AND RECEIVED A DOSE OF ANTIBIOTIC THERAPY AS PROPHYLAXIS JUST IN CASE. HE RECEIVED HIS HEMODIALYSIS TREATMENT VIA THE TEGO PLUGS ON HIS HEMODIALYSIS CATHETER. THERE WAS NO HOLE, CUT, TEARS OR ANY DEFECT NOTED. THERE WAS SOME BLOOD IN THE TEGO PLUG WHICH MAY BE NORMAL. THE EXTERIOR WAS INTACT TO THE EYE. THEY DID NOT ATTEMPT TO IRRIGATE TO SEE IF THERE WAS AN INVISIBLE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750231 TEGO® CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED ANTIBIOTIC, MFR UNK