BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPLIT SEPTUM MICRO T-CONNECTOR

    MDR report key: 10157421 · Received June 16, 2020

    Report

    Report Number
    10157421
    Event Type
    Malfunction
    Date Received
    June 16, 2020
    Date of Event
    June 3, 2020
    Report Date
    June 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

    WHILE ASSESSING THE PATIENT AND PERFORMING CARES, RN NOTICED A SMALL LEAK/CRACK OF THE HUMMI TUBING ATTACHED TO THE RED PORT OF THE PICC LINE. THE FLUID WAS LEAKING WHERE THE TUBING CONNECTS TO THE HARD PLASTIC ON THE HUMMI SIDE OF THE TUBING. RED PORT OF THE PICC LINE WAS CLAMPED, NEW FLUIDS WERE ORDERED FROM PHARMACY, NEW TUBING AND FLUID WERE HUNG WITH A NEW HUMMI ATTACHED. NNP WAS NOTIFIED OF THE LEAKING HUMMI. THE HUMMI TUBING WAS SAVED AND PASSED ONTO THE EDUCATORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620190 SPLIT SEPTUM MICRO T-CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA HUMMINGBIRD MED DEVICES INC NMT8046 19039

    Patients

    Seq Age Sex Outcome Treatment
    1 60 DA