BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOOD DRAW TRANSFER DEVICE

    MDR report key: 6545515 · Received May 4, 2017

    Report

    Report Number
    3009382876-2017-00001
    Event Type
    Injury
    Date Received
    May 4, 2017
    Manufacturer
    HUMMINGBIRD MED DEVICES, INC.
    Product Code
    KST
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    Z-1908-2016
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HUMMINGBIRD MED RECEIVED A PRODUCT COMPLAINT FROM BAXTER HEALTHCARE INVOLVING THEIR INTERLINK T-CONNECTOR WHEN USED WITH A HUMMI MICRO DRAW BLOOD TRANSFER DEVICE. THE CUSTOMER TRIED TO INSERT THE HUMMI'S BLUNT CANNULA IN THE MIDDLE OF THE INTERLINK T-CONNECTOR PORT. THE T-CONNECTOR'S PORT CAVED-IN AND THE PATIENT STARTED BLEEDING OUT. THE HOSPITAL DID NOT KNOW HOW MUCH BLOOD WAS LOST FROM THE PATIENT BUT THE PATIENT DID NEED A BLOOD TRANSFUSION. HUMMINGBIRD MED HAS INFORMED THE HOSPITAL OF IMPROPER USE OF THE HUMMI AND TO USE IT ONLY WITH AN APPROVED MICRO-T CONNECTOR VALIDATED FOR USE WITH THE HUMMI.

    Description of Event or Problem · 1

    HUMMINGBIRD MED RECEIVED A PRODUCT COMPLAINT FROM BAXTER HEALTHCARE INVOLVING THEIR INTERLINK T-CONNECTOR WHEN USED WITH A HUMMINGBIRD MED HUMMI MICRO DRAW BLOOD TRANSFER DEVICE. THE CUSTOMER TRIED TO INSERT THE HUMMI BLUNT CANNULA IN THE MIDDLE OF THE INTERLINK T-CONNECTOR PORT. THE T-CONNECTOR PORT CAVED-IN AND PATIENT STARTED BLEEDING OUT. THE HOSPITAL DID NOT KNOW HOW MUCH BLOOD WAS LOST FROM PATIENT BUT THE PATIENT DID NEED A BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326871 BLOOD DRAW TRANSFER DEVICE KST HUMMINGBIRD MED DEVICES, INC. ABG-HM-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1