BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 3213056 · Received March 22, 2013

    Report

    Report Number
    2411236-2013-00001
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    November 6, 2012
    Report Date
    March 7, 2013
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE NEEDLE ON A (B)(6) FEMALE PATIENT THE NEEDLE SEPARATED FROM THE HUB AND WAS LODGED IN TISSUE. THE NEEDLE HAD TO BE SURGICALLY REMOVED. LOT NUMBER CORRECTED TO 11I11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121204 HENRY SCHEIN HYPODERMIC NEEDLE FMI NIPRO MEDICAL CORPORATION 11I11

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R