BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO CONNECTOR

    MDR report key: 4996484 · Received August 10, 2015

    Report

    Report Number
    2025816-2015-00064
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    February 4, 2015
    Report Date
    May 19, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOT# 2883691 (MFG. 06/2014 SHOWED (B)(4) UNITS WERE MFG. TESTED INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. FINDINGS: THE INVOLVED DEVICES WERE NOT RETURNED FOR ANALYSIS AND CONFIRMATION. IT CANNOT BE DETERMINED WHETHER THE CONNECTING DEVICE COMPONENT LUERS WERE CRACKED/DAMAGED OR HOW/WHERE AIR WAS SEEN OR DETECTED OR WHETHER CLAMPING PROTOCOLS WERE FOLLOWED. TREATMENTS WERE REPORTEDLY NOT AFFECTED, NO REPORTED BLOOD/FLUID LEAKAGES. THE CAUSE OF THE EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    INT'L ((B)(6)) COMPLAINT RECEIVED CONCERNING AIR INLET ISSUE WITH USE OF DIALYSIS SET-UP CONSISTING OF TUNNELIZED JUGULAR CATHETER ARROW BLOODLINE 5008 FRESENIUS AND D1000 TEGO CONNECTORS. THE INITIAL INFORMATION RECEIVED REPORTS "...NURSE HAS NOTICED AIR INLET ISSUES IN THE VENOUS EXTERNAL ADAPTOR OF THE CATHETER.". THE INVOLVED TEGO CONNECTOR WAS REMOVED, REPLACED AND DISCARDED. THE TEGO CONNECTORS WERE REPORTEDLY IN USE FOR TWO DAYS. MEDICATIONS/DISINFECTING SOLUTION USED WERE IDENTIFIED AS FRAXIPARINE 0.6, VENOFER, NEORECORMON 4000, TAUROLOCK HEP 500; BISEPTINE TO DISINFECT THE TEGO CAP. THERE WERE NO REPORTED SERIOUS PATIENT INJURIES AND OR ADVERSE CONSEQUENCES. ADDITIONAL EVENT/USAGE INFORMATION HAS BEEN REQUESTED BUT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522051 TEGO CONNECTOR TEGO CONNECTOR FPA ICU MEDICAL, INC. D1000 2883691

    Patients

    Seq Age Sex Outcome Treatment
    1