BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICRO-FINE INSULIN PEN NEEDLE

    MDR report key: 4860050 · Received June 16, 2015

    Report

    Report Number
    2243072-2015-00102
    Event Type
    Injury
    Date Received
    June 16, 2015
    Date of Event
    May 25, 2015
    Report Date
    June 16, 2015
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK IF SAMPLE IS AVAILABLE FOR EVAL. A REVIEW OF THE DEVICE QUALITY NOTIFICATIONS REVEALED NO IRREGULARITIES FOR THE REPORTED LOT NUMBER 4072136. IF A SAMPLE IS RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A NURSE USED A BD MICRO-FINE INSULIN PEN NEEDLE TO INJECT INSULIN INTO A PT, THE PT END OF THE NEEDLE WAS MISSING WHEN THE NEEDLE WAS WITHDRAWN. THE PT REC'D AN X-RAY AND THE NEEDLE WAS NOT VISUALIZED. THE PT WAS CONCERNED THAT THE NEEDLE REMAINED IN THE INJECTION SITE SO AN ADD'L TWO X-RAYS WERE PROVIDED. NONE OF THE X-RAYS VISUALIZED THE NEEDLE. UPON FURTHER EVAL OF THE PEN NEEDLE, THE NURSE FOUND THE BROKEN PORTION OF THE NEEDLE IN THE INNER SHIELD OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392887 BD MICRO-FINE INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BD 4072136

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention