BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEGO CONNECTOR

    MDR report key: 2040168 · Received March 21, 2011

    Report

    Report Number
    2025816-2010-00090
    Event Type
    Other
    Date Received
    March 21, 2011
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S ANALYSIS AND INVESTIGATION: LOT RECORD ANALYSIS: 1653796 (MFG. DATE 05/2009) SHOWS 5100 UNITS; 1731582 (MFG. DATE 08/2009) SHOWS 5000 UNITS; 1732279 (MFG. DATE 08/2009) SHOWS 5000 UNITS, ALL WERE MANUFACTURED, TESTED, INSPECTED, AND RELEASED. INVESTIGATION OF RETURNED DEVICES: THE MFR RECEIVED A TOTAL OF THREE (3) USED D1000 TEGO CONNECTORS. VISUAL; FUNCTIONAL AND ADDITIONAL ENGINEERING TESTS WERE PERFORMED. VISUAL ANALYSIS RECORDED VARIOUS DAMAGES TO THE SEAL, HOUSING COMPONENTRY, PRESENCE OF RESIDUAL DRIED BLOOD TRAPPED BETWEEN THE SEALS AND HOUSING. FUNCTIONAL PERFORMANCE TESTING RECORDED LEAKAGES WITH TWO (2) OF THE THREE (3) RETURNED TEGO CONNECTORS. THE ENGINEERING INVESTIGATIONS/ANALYSIS INTO THESE FINDINGS DOCUMENTED THAT BASED ON THE EXTENT AND LOCATION OF THE DAMAGE/TEARS TO THE SILICONE SEALS THE TEARS MATCHED THE CURVATURE OF THE CONNECTOR POSTS INSIDE THE HOUSING. SINCE THERE IS A THREAD STOP ON THE HOUSING, IT IS LIKELY THAT THE DAMAGE WAS CAUSED BY EXCESSIVE FORCE, OVER TIGHTENING AND OR OFF-CENTER ACCESS WITH A LONG MALE LUER SLIP TYPE CONNECTOR(S) WHILE ATTACHING/DETACHING. THE INVOLVED TEGO DEVICE AND DIALYSIS TUBING SET ASSOCIATED WITH THE FLOW/AIR ISSUE WAS NOT RETURNED FOR ANALYSIS AND INVESTIGATION. ALL OF THE IDENTIFIED MANUFACTURING AND COMPLAINT DATABASE RECORD ANALYSIS SHOW THE TEGO DEVICES WERE MANUFACTURED TO SPECIFICATION, TESTED, INSPECTED AND RELEASED. ON (B)(6) 2010 ICU MEDICAL INTERNATIONAL PRODUCT SERVICE SPECIALISTS PERFORMED ADDITIONAL TRAINING AND IN-SERVICING. THE DISTRIBUTOR AND FACILITIES WERE PROVIDED POSTERS, TRAINING MATERIALS TO EMPHASIZE INTENDED USAGE AND CORRECT CLINICAL TECHNIQUES. CORRECTIVE ACTIONS INCLUDED EDUCATIONAL TRAINING SESSIONS, EDUCATIONAL MATERIALS/POSTERS AND FOLLOW-UP IN-SERVICING. FEEDBACK FROM THE FACILITIES CLINICAL EDUCATORS SHOWED AN UNDERSTANDING AND ACCEPTANCE OF THE EDUCATION REQUIREMENTS THAT MAYBE REQUIRED DUE TO THE FACT THAT FOR MANY THIS WAS THE FIRST TIME ANY OF THEIR STAFF HAD EVER UTILIZED NEEDLE FREE, MICROBIOLOGICALLY AND MECHANICALLY CLOSED CONNECTORS AND THEREFORE NEEDED MORE TIME/TRAINING TO BE LESS AGGRESSIVE IN THEIR CONNECTION PROCESSES/MANNER. (B)(4).

    Description of Event or Problem · 1

    INTERNATIONAL ((B)(6)) COMPLAINTS RECEIVED FROM DISTRIBUTOR REPORTING LEAKAGE AND FLOW ISSUES WITH USE OF D1000 TEGO CONNECTORS AND VARIOUS DIALYSIS TUBING SETS, ACCESS & MATING DEVICES AND MONITORING EQUIPMENT (NOI). THE EVENT DATES WERE REPORTED AS (B)(6) 2009; (B)(6) 2010. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES ASSOCIATED WITH THE REPORTED EVENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 MONITORING EQUIPMENT| FRESENIUS DIALYSIS TUBING SETS| 20ML BD PLASTIPAK SYRINGES| 10ML BD PLASTIPAK SYRINGES| 10ML BD SALINE 0.9% SYRINGE| PUMP| NOI