BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO CONNECTOR

    MDR report key: 4120660 · Received July 28, 2014

    Report

    Report Number
    2025816-2014-00096
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    April 14, 2014
    Report Date
    July 22, 2014
    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

    DEVICE RETURN: ONE (1) USED D1000 TEGO CONNECTOR WAS RETURNED FOR ANALYSIS AND INVESTIGATION. VISUAL INSPECTION (PRE AND POST DECONTAMINATION) WAS PERFORMED. THE RESULTS RECORDED THE TEGO CONNECTOR EXHIBITED VARIOUS COMPONENT DAMAGES INCLUDING TEARS AT THE END OF THE SILICONE SEAL SLIT. ENGINEERING ANALYSIS: THE RETURNED TEGO CONNECTOR WAS PRESSURE LEAK TESTED PER THE APPLICABLE PRODUCT SPECIFICATIONS. THE RESULTS RECORDED LEAKAGES ORIGINATING FROM THE TEARS AT THE END OF THE SILICONE SEAL SLIT. ALTHOUGH NOT ALWAYS REPEATABLE, PREVIOUS INVESTIGATIONS AND ENGINEERING EFFORTS HAVE REPLICATED COMPONENT DAMAGES AND LEAKAGES THAT WERE ATTRIBUTABLE TO INCORRECT USAGE/TECHNIQUES INCLUDING: OFF CENTER INSERTIONS AND/OR OFF-CENTER ACCESS WITH A LONG MALE LUER SLIP TYPE CONNECTOR(S) WHILE ATTACHING / DETACHING; OVER TIGHTENING AND USE OF NON-COMPATIBLE MATING/ACCESS DEVICES THAT FAIL TO MEET THE ISO STANDARD 594/2. THE D1000 TEGO CONNECTOR DIRECTIONS FOR USE (DFU) PROVIDES INSTRUCTIONS AND CAUTIONS FOR THESE DESCRIBED USAGE CONDITIONS. A REVIEW OF THE MFG. LOT DATABASE FOR THE REPORTED LOT #2752040 (MFG. DATE 10/2013) ALSO SHOWS (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED, AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. FINDINGS: ENGINEERING TESTING AND ANALYSIS OF THE ONE RETURNED TEGO CONNECTOR REPLICATED THE REPORTED LEAKAGE ISSUE. THE ROOT CAUSE FO THE LEAKAGE WAS ATTRIBUTABLE TO COMPONENT DAMAGES TO THE SILICONE SEAL SLIT THAT MOST LIKELY OCCURRED AS A RESULT OF INCORRECT USAGE/TECHNIQUES. IT IS THE MANUFACTURER'S RECOMMENDATION THAT THE PRODUCT REPRESENTATIVES MEET WITH THE CLINICAL STAFF TO REVIEW AND COLLECT CONNECTION DEVICES USED WITH THE D1000 TEGO CONNECTORS. THIS REPORT AND THE ASSOCIATED INFORMATION HAVE BEEN PROVIDED TO THE DISTRIBUTOR AND REPORTING FACILITY FOR THEIR REVIEW AND RECORDS.

    Description of Event or Problem · 1

    INTL ((B)(4)) COMPLAINT RECEIVED CONCERNING LEAKAGE ISSUE WITH USE OF DIALYSIS SET-UP WHERE D1000 TEGO CONNECTOR WAS IN PLACE. THE INITIAL (AS TRANSLATED) INFORMATION RECEIVED REPORTS "...BLOOD LEAK OF THE TEGO AT THE SLIT OF THE ANTI-RETURN VALVE NOTICED WHEN DISCONNECTING THE PATIENT TO RINSE THE VENOUS BRANCH..." IT IS THE MFR'S. UNDERSTANDING THAT THERE WERE NO ADVERSE PT. CONSEQUENCES OR OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439870 TEGO CONNECTOR TEGO CONNECTOR FPA ICU MEDICAL, INC. D1000 2752040

    Patients

    Seq Age Sex Outcome Treatment
    1 NI TUBING LINES| UNKNOWN DIALYSIS CATHETER