BEUDAMED
    FDA Adverse Event Other Summary report: N

    TEGO CONNECTOR

    MDR report key: 2040166 · Received March 21, 2011

    Report

    Report Number
    2025816-2010-00108
    Event Type
    Other
    Date Received
    March 21, 2011
    Date of Event
    July 7, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFGERS INVESTIGATION: THE INVOLVED DEVICES WERE NOT RETURNED FOR ANALYSIS AND CONFIRMATION. A REVIEW OF THE MFG. LOT RECORDS FOR LOT # 1806753 (MFG. DATE (B)(4) 2009) SHOWS (B)(4) UNITS WERE MFG, TESTED, INSPECTED AND RELEASED. THE EXACT CAUSE(S) OF THE REPORTED DEVICE PROBLEMS ARE UNK. THE MANUFACTURER HAS MET WITH THE DISTRIBUTOR'S (B)(4) AND (B)(4) TO REVIEW THE TEGO CONNECTOR DEVICE APPLICATIONS, FACILITY TRAINING PROTOCOLS AND ASCERTAIN THEIR UNDERSTANDING OF THE DEVICE COMPONENTRY, PERFORMANCE FEATURES AND INTENDED FUNCTIONS.

    Description of Event or Problem · 1

    INTL (B)(6) COMPLAINT REC'D REPORTING LEAKAGE INCIDENT WITH USE OF ONE (1) D1000 TEGO CONNECTORS, UNK HEMODIALYSIS SET, CATHETER AND SYRINGE ACCESSORY DEVICES. THE DISTRIBUTOR'S REPORT STATES "LEAKAGE OF BLOOD NOTICED BY THE NURSE AT THE LEVEL OF THE SILICONE CHECK-VALVE OF THE TEGO THAT CLOSES A CENTRAL JUGULAR CATHETER." THE REPORT FURTHER STATES "BLOOD LEAKAGE AND AIR ENTRY WITHIN THE LUMEN OF THE CATHETER." THE DEVICES WERE CHANGED OUT AND DISCARDED. THERE WAS NO REPORTED ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEGO CONNECTOR CONNECTOR FPA ICU MEDICAL INC. D1000 1806753

    Patients

    Seq Age Sex Outcome Treatment
    1 SYRINGE| NOI| DIALYSIS EXT. SET| CATHETER