BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO CONNECTOR

    MDR report key: 6055281 · Received October 25, 2016

    Report

    Report Number
    2025816-2016-00093
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Report Date
    August 11, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K053106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING LOT BUILD REVIEW: A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOT# 3200037 (MFG. 03/2016) SHOWED (B)(4) UNITS WERE MFG., TESTED, INSPECTED AND RELASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. AS THE INVOLVED DEVICES WERE NOT RETURNED FOR ANALYSIS AND CONFIRMATION THE EXACT CAUSE(S) OF THE EVENTS/ISSUES ARE UNKNOWN. UPON REMOVAL OF THE INVOLVED TEGO CONNECTOR THERE WERE NO VISUALLY OBSERVED COMPONENT DAMAGES AND OR ABNORMALITIES. THIS REPORT AND THE ASSOCIATED INFORMATION HAVE BEEN ENTERED IN THE MFGERS. DATABASE FOR ANALYSIS AND TRENDING. DEVICE(S) NOT RETURNED.

    Description of Event or Problem · 1

    INT'L. ((B)(6)) COMPLAINT RECEIVED REPORTING LEAKAGES WITH USE OF D1000 TEGO CONNECTORS. THE INITIAL INFORMATION RECEIVED REPORTS INTERMITTENT OCCURRENCES IN (B)(6) THAT WERE DESCRIBED AS FOLLOWS, " WHEN FLUSHING CVC WITH NORMAL SALINE, SOMETHING SEEMED TO "BREAK" AND BLOOD THEN LEAKED FROM THE TEGO SEPTUM." TEGO WAS IN USE FOR THREE DAYS, ISSUE OCCURRED WITH SECOND ACCESS/SESSION. A SECOND EVENT OCCURRED WHERE ATTENDING CLINICIAN REPORTS "WHEN FLUSHING CVC WITH SALINE, TEGO CAP LEAKED BLOOD. APPEARED TO BE LEAKING FROM THE INSIDE (SEPTUM) AND NOT AT THE CONNECTION SITE". THIS TEGO WAS ALSO IN USE FOR THREE DAYS, ISSUE OCCURRED WITH SECOND ACCESS/SESSION. THE THIRD OCCURRENCE REPORTS " PRE-DIALYSIS THE TEGO CONNECTOR HAD BLOOD IN IT BETWEEN THE CLEAR "SILICONE COVER" AND THE HARD YELLOW INSIDE SURFACE. THE VALVE WAS INTACT .. TEGO LEAKING". THIS TEGO WAS ALSO IN USE FOR THREE DAYS, ISSUE OCCURRED PRIOR TO SECOND ACCESS/SESSION. IN EACH OF THE REPORTED EVENTS, THE TEGO CONNECTORS WERE REMOVED, REPLACED AND DISCARDED. THERE WERE NO REPORTED PATIENT INJURIES, CHANGES IN BASELINE CONDITION AND OR ADVERSE CONSEQUENCES. THE MFGER. HAS REQUESTED ADDITIONAL EVENT INFORMATION AS WELL AS THE RETURN STATUS OF THE INVOLVED DEVICES. AS OF THE DATE OF THIS SUBMISSION THERE HAS BEEN NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706163 TEGO CONNECTOR TEGO CONNECTOR FPA ICU MEDICAL, INC. D1000 3200037

    Patients

    Seq Age Sex Outcome Treatment
    1 PALINDROME CATHETER, BLOODLINES, BD SYRINGES NOI