BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO CONNECTOR

    MDR report key: 4437857 · Received December 15, 2014

    Report

    Report Number
    2025816-2014-00151
    Event Type
    Malfunction
    Date Received
    December 15, 2014
    Date of Event
    September 27, 2014
    Report Date
    October 13, 2014
    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

    INVESTIGATION: CODE: OTHER - A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOT# 2820490 (MFG. DATE 02/2014) SHOWS (B)(4) UNITS WERE MFG., TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. CONCLUSION: THE INVOLVED DEVICES WERE NOT RETURNED FOR ANALYSIS AND CONFIRMATION. THE REPORTED INFORMATION DID NOT IDENTIFY ANY VISUAL DEFECTS, COMPONENT DAMAGES WITH THE TEGO CONNECTORS. THE EXACT CAUSE(S) OF THE REPORTED EVENT ARE UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    INT'L COMPLAINT ((B)(4)) RECEIVED REPORTING AIR LEAKS WITH USE OF DIALYSIS SET-UP CONSISTING OF PALINDROME CATHETER; BLOODLINE BAXTER/GAMBRO/HOSPAL ARTIS REF. (B)(4) TEGO CONNECTORS. THE INITIAL INFORMATION (AS TRANSLATED) REPORTS "PRESENCE OF AIR INSIDE THE ARTERIAL BRANCH OF THE PALINDROME CATHETER, WITHOUT CRACK. THE TEGO CAPS WERE SUSPECTED.". THE TEGO CONNECTORS WERE REMOVED AND DISCARDED. THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES. THE TEGO MANUFACTURER HAS REQUESTED ADDITIONAL EVENT INFORMATION AND REQUEST FOR SAME LOT SAMPLES. AS OF THE DATE OF THIS REPORT THERE HAS BEEN NO RESPONSE. INVESTIGATION: A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOT# 2820490 (MFG DATE 02/2014) SHOWS (B)(4) UNITS WERE MFG., TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821807 TEGO CONNECTOR TEGO CONNECTOR FPA ICU MEDICAL, INC. D1000 2820490

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PALINDROME DIALYSIS TUNNELED CATHETER| BAXTER/GAMBO BLOOD LINES