BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HDNDL-E 22 X 1/2 IN I BLUE 11M

    MDR report key: 1122163 · Received August 14, 2008

    Report

    Report Number
    1017768-2008-00018
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    January 1, 2008
    Report Date
    August 8, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD A PROBLEM WITH A NEEDLE. THE CUSTOMER REPORTS THE NEEDLE AND HUB IS DETACHING BECAUSE THEY DON'T HAVE EPOXY IN THE UNION OF THE CANNULA AND HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HDNDL-E 22 X 1/2 IN I BLUE 11M NEEDLE FMI TYCO HEALTHCARE/KENDALL 7777128797 703695

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN