BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO CONNECTOR

    MDR report key: 5925062 · Received September 2, 2016

    Report

    Report Number
    2025816-2016-00077
    Event Type
    Malfunction
    Date Received
    September 2, 2016
    Report Date
    May 26, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K053106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MFG. LOT BUILD REVIEW: A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE TWO REPORTED LOT# 2958834 (MFG. 11/2014) SHOWED (B)(4) UNITS AND LOT# 2883691 (MFG. 06/2014) ALSO SHOWED (B)(4) UNITS WERE MFG. TESTED INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. THE INVOLVED DEVICES OR SAME LOT SAMPLES WERE NOT RETURNED FOR ANALYSIS AND CONFIRMATION. THE EXACT CAUSE(S) OF THE REPORTED EVENT(S) ISSUES ARE UNKNOWN AT THIS TIME. THE MFGER. WILL CONTINUE TO MONITOR AND TREND THESE TYPES OF REPORTED PRODUCT ISSUES AND INITIATE PREVENTATIVE MEASURES AS APPLICABLE. DEVICES NOT RETURNED.

    Description of Event or Problem · 1

    INT'L. (B)(6) COMPLAINT RECEIVED REPORTING COMPONENT DAMAGES/AIR IN LINE WITH USE OF SET-UP CONSISTING OF GAMBRO HOSPAL 6 ARTISETHD (REF. HDDNLHC / 115511) AND TEGO CONNECTORS. DISTRIBUTOR (AS TRANSLATED ) REPORTS TWO EVENT/ISSUES AS FOLLOWS "DURING A DIALYSIS SESSION, BEFORE THE CATHETER CONNECTION NOTICED DAMAGES ON THE CONNECTOR OF THE CATHETER WITH A CRACK, LEADING TO AIR INLET. THIS DEFECT SEEMS DUE TO THE SUCCESSIVE CONNECTIONS AND DISCONNECTIONS OF THE TEGO CAP USED ON THE 2 CATHETER LUMENS. THE TEGO CAP SEEMS TO HAVE A TIGHT SCREW THREAD AND OBLIGES TO USE SOME STRENGTH TO CONNECT IT ON THE CONNECTOR OF THE CATHETER AND IMPAIRS IT. FIRST THOUGHT THAT THE CATHETER WAS THE PROBLEM BUT WE REALIZED THAT IS A CONNECTION ISSUE, WITH THE TOO TIGHTLY SCREWED TEGO CAPS." FOLLOW UP INFORMATION ALSO REPORTS THE TEGO CONNECTORS WERE IN USE FOUR DAYS, WHERE UNSPECIFIED NUMBER OF INFUSIONS, TREATMENTS WERE ADMINISTERED WITHOUT ISSUES. MEDICATIONS/DRUGS ADMINISTERED IDENTIFIED AS LOVENOX, ARANESP, IRON, HEPARINE. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES AND OR OUTCOMES. ALTHOUGH REQUESTED NO RESPONSES TO REQUESTS FOR ADDITIONAL EVENT INFORMATION AND STATUS OF DEVICE(S) AVAILABLE TO BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576048 TEGO CONNECTOR TEGO CONNECTOR FPA ICU MEDICAL, INC. D1000 2958834; 2883691

    Patients

    Seq Age Sex Outcome Treatment
    1 GAMBRO HOSPAL 6 ARTISETHD (REF. HDDNLHC / (B)(4)