BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO CONNECTOR

    MDR report key: 5535945 · Received March 30, 2016

    Report

    Report Number
    2025816-2016-00022
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Date of Event
    December 19, 2015
    Report Date
    March 7, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K053106
    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. ALTHOUGH REQUESTED THE INVOLVED SET-UP/MATING DEVICES WERE NOT RETURNED. QE TESTING AND ANALYSIS: VISUAL INSPECTION (PRE AND POST DECONTAMINATION) RECORDED EXTENSIVE COMPONENT DAMAGES MOST NOTABLY ON BOTH CORNERS OF THE SLIT ON THE FEMALE LUER. FUNCTIONAL TESTING TO THE APPLICABLE PRODUCT SPECIFICATIONS RECORDED THE RETURNED TEGO CONNECTOR FAILED PRESSURE TESTING. THE REPORT ALSO DOCUMENTED TESTS CONDUCTED WITH FLUID AT 3.0 PSI RECORDED LEAKAGE ORIGINATING FROM THE DAMAGED CORNER OF THE SLIT. LOT BUILD RECORD REVIEW: A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOT# 3040554 (MFG. DATE 04/2015) SHOWED (B)(4) UNITS WERE MFG. TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. FINDINGS: ENGINEERING ANALYSIS OF THE ONE RETURNED USED D1000 TEGO CONNECTOR CONFIRMED EXTENSIVE COMPONENT DAMAGES/LEAKAGE. THE CHARACTERISTICS OF THE COMPONENT DAMAGES ARE CONSISTENT WITH INCORRECT USAGE / ACCESS WITH INCOMPATIBLE MATING/ACCESS DEVICES AND NOT AS A RESULT OF THE ASSEMBLY/MFG. PROCESSES. AS STATED ON THE DIRECTIONS FOR USE (DFU) THE D1000 TEGO CONNECTOR SHOULD ONLY BE ACCESSED WITH A ISO COMPLIANT MALE LUER.

    Description of Event or Problem · 1

    INT'L. ((B)(6)) COMPLAINT RECEIVED REPORTING LEAKAGE/AIR IN LINE ISSUES WITH USE OF DIALYSIS SET-UP CONSISTING OF MEDCOMP CANAUD (B)(4); FRESENIUS BLOODLINE SET AND TEGO CONNECTORS. THE DISTRIBUTOR REPORTS "LEAK DETECTED DURING THE CONNECTION, AT THE LEVEL OF THE TEGO, WHEN CONNECTING THE BLOODLINES AND THE CATHETER. SOME AIR ALARMS OCCURRED ON THE DIALYSIS MACHINE, IT MIGHT BE DUE TO THE CANAUD CATHETER. HOWEVER, THE AIR ALARMS STOP WHEN THE TEGO CAP IS REMOVED. THIS ISSUE HAPPENED TWICE WITH THE SAME PATIENT. HAD TO CHANGE THE CATHETER." THE TEGO CONNECTORS WERE IN USE FIVE (5) DAYS, WHERE UNSPECIFIED NUMBER OF TREATMENTS WERE SUCCESSFULLY ADMINISTERED. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191789 TEGO CONNECTOR TEGO CONNECTOR FPA ICU MEDICAL, INC. D1000 3040554

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDCOMP CANAUD (B)(4)