BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPLIT SEPTUM MICRO T-CONNECTOR

    MDR report key: 18325146 · Received December 14, 2023

    Report

    Report Number
    18325146
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    October 12, 2023
    Report Date
    October 19, 2023
    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
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT MOM HOLDING PATIENT. MOM ALERTED REGISTERED NURSE (RN) OF BLOOD ON HER COMING FROM PATIENT'S PICC LINE. NURSE ASSESSED AND SAW THAT BLOOD WAS BACK FLOWING FROM THE RED LUMEN. RED LUMEN CLAMPED, EMERGENT LINE CHANGE DONE WITH NEW HUMMI T-CONNECTOR PLACED. HUMMI T-CONNECTOR FLUSHED APPROPRIATELY WITH NO NOTABLE CRACKS OR LEAKS. HOWEVER, THE HUB OF THE HUMMI T-CONNECTOR HAS DRIED BLOOD AROUND THE HUB THAT CONFIRMS THE BACKFLOW OF BLOOD. PRODUCT: MINIBORE EXTENSION SET WITH SPLIT SEPTUM MICRO T-CONNECTOR, LOT 23110, REORDER NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769997 SPLIT SEPTUM MICRO T-CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA HUMMINGBIRD MED DEVICES INC NMT8046 23110

    Patients

    Seq Age Sex Outcome Treatment
    1 30 DA Male