BEUDAMED
    FDA Adverse Event Other Summary report: N

    PIC INSUPEN

    MDR report key: 2782046 · Received September 25, 2012

    Report

    Report Number
    9612764-2012-00002
    Event Type
    Other
    Date Received
    September 25, 2012
    Report Date
    September 7, 2012
    Manufacturer
    ARTSANA S.P.A.
    Product Code
    FMI
    PMA / PMN Number
    K051783
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PEN NEEDLE HAS BROKEN INSIDE THE STOMACH OF THE PATIENT ((B)(4)). THE NEEDLE HAS BEEN REMOVED. WE HAVE NOT RECEIVED THE SUSPECTED DEVICE. WE MADE ANALYSIS ON THE SAMPLE OF THE SAME LOT WITH RESULT: COMPLIANCE. DURING THE LOT RELEASE WERE CONTROLLED 10 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 STRICTER) INJECTION CONTROL ACCORDING TO DIN (B)(4) CONTROL AT 100% OF THE NEEDLE OBTURATION. AS PER THE ABOVE WE CAN ASSUME THAT THE INCIDENT COULD HAVE BEEN CAUSED BY A REUSE OF A SINGLE USE DEVICE. THE INDICATION OF SINGLE USE IS CLEARLY INSERT ON THE PRODUCT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC INSUPEN PEN NEEDLE FMI ARTSANA S.P.A. 1010751

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization