BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO CONNECTOR

    MDR report key: 10696157 · Received October 19, 2020

    Report

    Report Number
    9617594-2020-00451
    Event Type
    Malfunction
    Date Received
    October 19, 2020
    Date of Event
    September 15, 2020
    Report Date
    September 28, 2020
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K053106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10 - ONE USED LIST# 011-D1005, TEGO¿ CONNECTOR. LOT# UNKNOWN, ONE NEW LIST# 011-D1005, TEGO¿ CONNECTOR. LOT# 4030802 AND ONE NEW LIST# 011-D1005, TEGO¿ CONNECTOR. LOT# 4047370 WERE RECEIVED FOR EVALUATION. THE COMPLAINT OF DISCONNECTION ON THE ONE USED AND TWO NEW D1005 TEGO CONNECTOR COULD NOT BE CONFIRMED OR REPLICATED. THERE WAS NO MATING DEVICE RETURNED FOR EVALUATION. THERE WAS NO DISCONNECTION OR LEAKAGE DURING FUNCTIONAL TESTING. EACH D1005 TEGO CONNECTORS MET PRESSURE AND VACUUM PERFORMANCE EXPECTATION OUTLINE IN THE PRODUCT SPECIFICATION. THE MALE LURE OF THE TEGO CONNECTOR AND THE THREADS ARE ISO COMPLIANT. EACH RETURNED D1005 TEGO MET PRODUCT SPECIFICATIONS. A DEVICE HISTORY REVIEW FOR LOT# 4030802 AND 4047370 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION CAN BE FOUND IN SECTIONS A3 AND B5.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THAT THE BIRTH YEAR OF THE PATIENT WAS 1928.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT BEEN RECEIVED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER IDENTIFIED TWO POSSIBLE LOT NUMBERS (PLOTS). THE POSSIBLE LOT NUMBERS ARE 4047370 (EXPIRY DATE 04/01/2024 , MFR DATE 04/01/2019), AND 4030802 (EXPIRY DATE 04/01/2024, MFR DATE 03/01/2019).

    Description of Event or Problem · 1

    THE EVENT INVOLVED A TEGO® CONNECTOR WHERE THE FRESENIUS VENOUS LINE DISCONNECTED FROM A TEGO CONNECTOR A FEW MINUTES AFTER THE START OF DIALYSIS. THIS LED TO A BLOOD LOSS OF ABOUT 200 ML. THE PATIENT WAS CHECKED BY A PHYSICIAN FOLLOWING THE EVENT, WITH THE PATIENT BEING STABLE. THERE WAS NO DEFECT NOTED ON THE AFFECTED SAMPLE. THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM, OR DELAY IN CRITICAL THERAPY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163717 TEGO CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPEC VENOUS LINE, MFR FRESENIUS| UNSPEC VENOUS LINE, MFR FRESENIUS