BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMMI

    MDR report key: 5316424 · Received December 21, 2015

    Report

    Report Number
    3009382876-2015-00003
    Event Type
    Malfunction
    Date Received
    December 21, 2015
    Date of Event
    November 16, 2015
    Report Date
    December 16, 2015
    Manufacturer
    HUMMINGBIRD MED DEVICES, INC.
    Product Code
    KST
    Removal / Correction Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OF SEPARATION BETWEEN THE HUB OF THE CANNULA ASSEMBLY AND THE Y CONNECTOR PRIOR TO BEING USED IN PATIENTS RESULTED IN EXPANDING THE LOT NUMBERS IMPACTED BY THIS SEPARATION FAILURE THUS ALSO EXPANDING THE RECALL LOTS AFFECTED TO NOW INCLUDE THE ORIGINAL LOT 15180 PLUS NEW LOTS: 15286, 15287, 15300, AND 15305 - CURRENTLY IN-PROGRESS AND THIS WAS ALSO REPORTED TO (B)(6) AUTHORITIES IN THE (B)(6) OFFICES (MS (B)(6)). A CORRECTIVE ACTION TO USE ULTRAVIOLET LIGHT FOR BONDING WITH LOCTITE ADHESIVE HAS ALSO BEEN IMPLEMENTED AND NOW BEING PROVIDED TO ALL AFFECTED PARTIES REQUESTING PRODUCT REPLACEMENTS.

    Description of Event or Problem · 1

    THE HUB OF THE PRODUCT DISCONNECTED FROM THE Y CONNECTOR PRIOR TO PRODUCT USE DURING PRODUCT HANDLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843085 HUMMI BLOOD DRAW TRANSFER DEVICE KST HUMMINGBIRD MED DEVICES, INC. ABG-HM-1 15286

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown