BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMMI

    MDR report key: 5316435 · Received December 21, 2015

    Report

    Report Number
    3009382876-2015-00004
    Event Type
    Malfunction
    Date Received
    December 21, 2015
    Manufacturer
    HUMMINGBIRD MED DEVICES, INC.
    Product Code
    KST
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED DEVICE CONFIRMED SEPARATION BETWEEN HUB OF CANNULA AND Y-CONNECTOR IS IDENTICAL TO THAT WHICH IS UNDER RECALL AND THE LOT NUMBER (15300) IS UNDER SCOPE OF THE RECALLED LOT NUMBERS.

    Description of Event or Problem · 1

    DURING USE THE HUB OF THE CANNULA SEPARATED FROM THE Y-CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843086 HUMMI BLOOD DRAW TRANSFER DEVICE KST HUMMINGBIRD MED DEVICES, INC. ABG-HM-1 15300

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown