BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPLIT SEPTUM MICRO T-CONNECTOR

    MDR report key: 10747397 · Received October 28, 2020

    Report

    Report Number
    10747397
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    September 29, 2020
    Report Date
    October 15, 2020
    Manufacturer
    HUMMINGBIRD MED DEVICES INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT RECEIVING TPN THROUGH DOUBLE LUMEN 2.6FR PICC LINE PLACED ON (DATE REDACTED). IT IS UNKNOWN BY THIS WRITER IF THE HUMMI HAD PREVIOUSLY BEEN CHANGED BUT IT IS CURRENT PRACTICE TO NOT ROUTINELY CHANGE THE HUMMI WITH Q96HR TUBING CHANGE. TODAY, WHEN PATIENT WEIGHED, IT WAS NOTICED BY THE BEDSIDE RN THAT THE LINE WAS BACKING UP WITH BLOOD AND LEAKING TPN/BLOOD INTO THE BED FROM THE RED LUMEN. LEAK IDENTIFIED AT HUMMI, LINE IMMEDIATELY CLAMPED ON EITHER SIDE OF LEAK AND RNTS CALLED TO BEDSIDE. RNTS (REGISTERED NURSE TRAUMA SPECIALIST) WITH BEDSIDE RN CHANGED OUT HUMMI. THE HUMMI WAS PUT IN THE MAILBOX OF THE NICU EDUCATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212786 SPLIT SEPTUM MICRO T-CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA HUMMINGBIRD MED DEVICES INC NMT8046 19293

    Patients

    Seq Age Sex Outcome Treatment
    1 150 DA