BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FIN III 31G X 5MM PEN NEEDLE

    MDR report key: 3964005 · Received July 9, 2014

    Report

    Report Number
    2243072-2014-00140
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS AVAILABLE FOR EVALUATION. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    WHEN THE PATIENT PULLED OUT THE NEEDLE AFTER AN INJECTIONS INTO THE STOMACH, THE POINT OF THE NEEDLE WAS OBSERVED TO BE MISSING. THE PATIENT WENT TO THE HOSPITAL AND GOT AN X-RAY, BUT NEEDLE WAS NOT FOUND AT THE INJECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402165 BD ULTRA-FIN III 31G X 5MM PEN NEEDLE INSULIN PEN NEEDLE FMI BD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK