BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NANOCLAVE CONNECTOR

    MDR report key: 9688014 · Received February 10, 2020

    Report

    Report Number
    9617594-2020-00043
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    January 1, 2020
    Report Date
    January 24, 2020
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619060909
    PMA / PMN Number
    K100434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ONE (1) NEW LIST# 011-A1000, NANOCLAVE¿ CONNECTOR, LOT# 3970567 WAS RECEIVED FOR TESTING ON (B)(6)2020. THE SINGLE NEW IN STERILE PACKAGE 011-A1000 NANOCLAVE CONNECTOR WAS FLOW TESTED AT GRAVITY PRESSURE AND THE 011-A1000 NANOCLAVE MET FLUID FLOW EXPECTATIONS OUTLINED IN THE PRODUCT PERFORMANCE SPECIFICATION. NO MATING DEVICES WERE RETURNED TO EVALUATE WITH THE 011-A1000 NANOCLAVE CONNECTOR. THE COMPLAINT WAS UNABLE TO BE CONFIRMED OR REPLICATED. A DHR (DEVICE HISTORY REVIEW) LOT# 3970567 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO RETURN TO THE MANUFACTURER FOR INVESTIGATION; IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE DATE OF THE EVENT IS UNKNOWN. THE EVENT INVOLVED A NANOCLAVE¿ CONNECTOR THAT DID NOT ALLOW FLOW WHEN THE ANESTHETIST ATTEMPTED TO INJECT EMERGENCY MEDICATIONS THROUGH THE CONNECTOR. THE CUSTOMER STATED IT WAS NEAR IMPOSSIBLE TO INJECT, EVEN WITH PRESSURE. THIS REPORT CAPTURES THE FIRST OF TWO INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153011 NANOCLAVE CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3970567 00840619060909

    Patients

    Seq Age Sex Outcome Treatment
    1