BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEGO

    MDR report key: 3252633 · Received July 18, 2013

    Report

    Report Number
    2025816-2013-00046
    Event Type
    Other
    Date Received
    July 18, 2013
    Date of Event
    February 16, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE MFR DATE: 07/2012. MFR'S INVESTIGATION: DEVICE RETURN: TWO (2) USED D1000 TEGO CONNECTORS WERE RETURNED FOR ANALYSIS AND INVESTIGATION. ALTHOUGH REQUESTED THE INVOLVED MATING/ACCESS DEVICES WERE NOT RETURNED FOR TESTING AND ANALYSIS WITH THE TEGO CONNECTOR. ENGINEERING TESTING AND ANALYSIS TO THE APPLICABLE TEGO PRODUCT SPECIFICATIONS WERE CONDUCTED. THE RESULTS RECORDED ONE OF THE TWO RETURNED D1000 CONNECTORS FAILED LEAK TESTING. THE ENGINEERING ANALYSIS REPORT IDENTIFIED THE SOURCE OF THE LEAKAGE WAS DUE TO THE TEAR IN THE CORNER OF THE TEGO SLIT. THE SECOND RETURNED TEGO CONNECTOR PASSED THE PERFORMANCE TESTING. THERE WERE NO RECORDED EXTERNAL LEAKAGES. THE TWO RETURNED TEGO CONNECTORS WERE DISASSEMBLED AND EVALUATED. THE RESULTS IDENTIFIED VARIOUS COMPONENT DAMAGES INCLUDING CORNER TEARS AT THE SLIT AND THREAD POST DAMAGES, INDICATIVE OF USAGE/OVER-TIGHTENING TECHNIQUE ERRORS. RECORD REVIEWS: (B)(4). THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE MFG BUILD CYCLES. ADDITIONAL EVALUATIONS: A REVIEW OF THE CURRENT MOLDING, ASSEMBLY PROCESSES AND APPLICABLE TOOLING AND EQUIPMENT WAS CONDUCTED TO DETERMINE IF ANY FIXTURES, EQUIPMENT OR MATERIAL HANDING CONDITIONS COULD POTENTIALLY CONTRIBUTE TO SLIT DAMAGE. THE RESULTS DID NOT IDENTIFY ANY IN-PROCESS CONTRIBUTING FACTORS. ICU MEDICALS CONTINUOUS IMPROVEMENT INITIATIVES AND ENGINEERING TEAM RESOURCES HAVE IMPLEMENTED HEIGHTENED INSPECTION OF THE APPLICABLE MANUFACTURING PROCESSES AND CONTINUE TO MONITOR FOR ANY POTENTIAL CONTRIBUTING FACTORS. CONCLUSION: ENGINEERING TESTING AND ANALYSIS REPLICATED A LEAKAGE FAILURE ATTRIBUTABLE TO COMPONENT DAMAGE ON ONE OF THE RETURNED USED D1000 TEGO CONNECTOR. THE EXACT CAUSE(S) OF THE COMPONENT DAMAGE/TEAR ON THE RETURNED USED D1000 TEGO CONNECTOR CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    INT'L. (B)(6) COMPLAINT RECEIVED REPORTING LEAKAGE ISSUES WITH USE OF D1000 TEGO CONNECTORS. IT WAS REPORTED THAT "..PATIENT HAS BEEN SENT TO THE CLOSEST HOSPITAL DUE TO LEAK ON HER TEGO CAPS". ALTHOUGH REQUESTED, ADDITIONAL RELEVANT INFO WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335268 TEGO CONNECTOR FPA ICU MEDICAL, INC. D1000 2504906; 2532103

    Patients

    Seq Age Sex Outcome Treatment
    1 NI DIALYSIS CATHETER| DIALYSIS TUBING LINE NOI