BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO CONNECTOR

    MDR report key: 4407253 · Received September 19, 2014

    Report

    Report Number
    2025816-2014-00105
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 28, 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

    ADDITIONAL ENGINEERING ANALYSIS WAS CONDUCTED. THE USED TEGO CONNECTOR WAS DISASSEMBLED. THE REPORT DOCUMENTS INTERNAL COMPONENT DAMAGES AND DOCUMENTS THE SILICONE ONE-PIECE SEAL HAD A SMALL PUNCTURE IN THE SIDEWALL. A SMALL AMOUNT OF PRESSURE WAS THEN APPLIED WHICH DID INDUCE FLUID LEAKAGE. THE ENGINEERS REPORT NOTED THAT THE CHARACTERISTICS OF THIS TYPE OF SEAL PUNCTURE AND LOCATION WITHIN THE SEAL IS TYPICAL OF ACCESS WITH A SHARP INSTRUMENT SUCH AS A NEEDLE. MFG. LOT BUILD RECORD REVIEW: A REVIEW OF THE MFG. LOT DATABASE FOR THE REPORTED LOT # 2813000 (MFG. DATE 01/2014) SHOWS (B)(4) UNITS WERE MFGD, TESTED, INSPECTED, AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. FINDINGS: ENGINEERING TESTING AND ANALYSIS OF THE PACKAGED SAME LOT SAMPLE RECORDED NO LEAKAGES, THE DEVICE MET THE PRODUCT SPECIFICATION. THE ANALYSIS OF THE RETURNED USED TEGO CONNECTOR DID CONFIRM LEAKAGE ISSUE DUE TO INTERNAL COMPONENT DAMAGES/PUNCTURE THROUGH THE ONE PIECE SILICONE SEAL. THE MOST LIKELY CAUSE OF THE COMPONENT DAMAGE IS ATTRIBUTABLE TO INCORRECT USAGE, WHERE ACCESS WITH A SHARP INSTRUMENT SUCH AS A NEEDLE OCCURRED. THIS REPORT AND THE ASSOCIATED INFO ARE BEING PROVIDED TO THE DIST AND REPORTING FACILITY FOR THEIR REVIEW AND RECORDS.

    Description of Event or Problem · 1

    INTL (B)(6) COMPLAINT RECEIVED CONCERNING LEAKAGE ISSUE WITH USE OF DIALYSIS SET-UP WHERE D1000 TEGO CONNECTOR WAS IN PLACE. THE INITIAL (AS TRANSLATED) INFO RECEIVED REPORTS "BLOOD LEAK OF THE TEGO ALONG THE SIDE OF THE TRANSPARENT SILICON MEMBRANE. CHANGE OF THE CAP: NO MORE LEAK..." IT IS THE MFGERS. UNDERSTANDING THAT THERE WERE NO ADVERSE PT CONSEQUENCES OR OUTCOMES. ADDITIONAL EVENT/DEVICE INFO INCLUDING AVAILABILITY OF THE INVOLVED MATING AND ACCESS DEVICES ALTHOUGH REQUESTED WERE NOT RESPONDED TO. DEVICE RETURN: ONE (1) USED D1000 TEGO CONNECTOR AND ONE PKGD. D1000 LOT# 2813000 WERE RETURNED FOR ANALYSIS AND INVESTIGATION. VISUAL ANALYSIS OF THE RETURNED USED TEGO CONNECTOR RECORDED EVIDENCE OF BLOOD LEAKAGE INTERNAL TO THE TEGO ASSEMBLY. THERE WERE NO OBVIOUS ABNORMALITIES WITH THE PACKAGED SAME LOT SAMPLE. ENGINEERING ANALYSIS: THE RETURNED TEGO CONNECTORS WERE BOTH PRESSURE LEAK TESTED PER THE APPLICABLE PRODUCT SPECIFICATION. THE REPORTS DOCUMENT BOTH DEVICES PASSED WITHOUT LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585374 TEGO CONNECTOR TEGO CONNECTOR FPA ICU MEDICAL, INC. D1000 2813000

    Patients

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