BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO CONNECTOR

    MDR report key: 4230274 · Received October 21, 2014

    Report

    Report Number
    2025816-2014-00120
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN: EIGHT (8) USED D1000 TEGO CONNECTORS VISUAL ANALYSIS OF THE RETURNED USED TEGO CONNECTORS RECORDED EVIDENCE OF BLOOD LEAKAGE INTERNAL TO THE TEGO ASSEMBLY. ENGINEERING ANALYSIS: THE TEGO CONNECTOR WERE EACH TESTED PER THE APPLICABLE PRODUCT SPECIFICATIONS. THE RESULTS RECORDED LEAKAGES WITH SEVEN OF THE TEGO CONNECTORS. MICROSCOPIC ANALYSIS OF THE RETURNED UNITS RECORDED VARIOUS COMPONENT DAMAGES/TEARS AT THE SLIT CORNERS. MFG. LOT BUILD RECORD REVIEW: A REVIEW OF THE MANUFACTURING LOT BUILD DATABASE FOR THE REPORTED LOT NUMBER 2830976 (MFG. DATE 03/2014) SHOWS (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED, AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. ALTHOUGH NOT ALWAYS REPEATABLE, PREVIOUS INVESTIGATIONS OF THESE TYPES OF TEGO COMPONENT DAMAGE/LEAKAGE ISSUES HAVE BEEN REPLICATED. THOSE INVESTIGATIONS IDENTIFIED VARIOUS USAGE/TECHNIQUES INCLUDING; OFF CENTER INSERTIONS AND OR OFF-CENTER ACCESS WITH A LONG MALE LUER SLIP TYPE CONNECTORS WHILE ATTACHING/DETACHING; OVER TIGHTENING AND USE OF NON-COMPATIBLE MATING/ACCESS DEVICES THAT FAIL TO MEET THE ISO STANDARD 594/2. FINDINGS: ENGINEERING TESTING AND ANALYSIS OF THE RETURNED USED TEGO CONNECTORS DID REPLICATE LEAKAGE ISSUES THAT WERE ATTRIBUTABLE TO COMPONENT DAMAGES. THE MOST LIKELY CAUSE OF THE COMPONENT DAMAGES ARE ATTRIBUTABLE TO INCORRECT USAGE AND OR TECHNIQUES. THIS REPORT AND THE ASSOCIATED INFORMATION ARE BEING PROVIDED TO THE DISTRIBUTOR AND REPORTING FACILITY FOR THEIR REVIEW AND RECORDS.

    Description of Event or Problem · 1

    (B)(4) ((B)(6)) COMPLAINT RECEIVED REPORT CONCERNING LEAKAGE ISSUES WITH USE OF DIALYSIS SET-UPS WHERE D1000 TEGO CONNECTORS WERE IN USE. IT IS THE MANUFACTURER'S. UNDERSTANDING THAT THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR OUTCOMES. ADDITIONAL EVENT/DEVICE INFORMATION ALTHOUGH REQUESTED WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667037 TEGO CONNECTOR TEGO CONNECTOR FPA ICU MEDICAL INC. D1000 2830976

    Patients

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