BEUDAMED
    FDA Adverse Event Other Summary report: N

    PIC INSUPEN

    MDR report key: 3192597 · Received May 21, 2012

    Report

    Report Number
    9612764-2013-00001
    Event Type
    Other
    Date Received
    May 21, 2012
    Date of Event
    April 29, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ARTSANA S.P.A.
    Product Code
    FMI
    PMA / PMN Number
    K051783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PEN NEEDLE HAS BROKEN INSIDE THE ABDOMEN OF THE PT ((B)(4)). THE NEEDLE HAS BEEN SURGICALLY REMOVED. WE MADE ANALYSIS OF THE SAMPLE OF THE SAME LOT WITH RESULT: COMPLIANCE. DURING THE LOT RELEASE WERE CONTROLLED, (B)(4) PEN NEEDLES IN ORDER TO CHECK THE CONFORMITY OF THE PRODUCT ACCORDING TO THE INJECTION, AND THE RESULT WAS: COMPLIANCE. THE OTHER CONTROLS PERFORMED WERE: VISUAL CONTROL WITH MAGNIFIER AT 40 INCREASES (ISO 11608-2 THAT REFERS TO ISO 7864 RECOMMEND A CONTROL AT 2,5 INCREASES, IT MEANS THAT OUR CONTROL IS STRICHTER). INJECTION CONTROL ACCORDING TO (B)(4). CONTROL AT 100% OF THE NEEDLE OBTURATION.

    Description of Event or Problem · 1

    THE PEN NEEDLE HAS BROKEN INSIDE THE ABDOMEN OF THE PT ((B)(4)). THE NEEDLE HAS BEEN SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC INSUPEN PEN NEEDLE FMI ARTSANA S.P.A. 104100372

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization