BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICRO-FINE PLUS 31GA PEN NEEDLE

    MDR report key: 3902208 · Received June 23, 2014

    Report

    Report Number
    2243072-2014-00134
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 DRAWING THE NEEDLE FROM THE ARM, THE NURSE SAW A SPOUT OF CLOUDY FLUID COMING FROM THE BROKEN END OF THE NEEDLE. WHEN LOOKING AT THE NEEDLE MORE CLOSELY, THE NURSE NOTICED THAT THERE WAS NO NEEDLE WITHIN THE HUB AND NOTICED IT HAD SNAPPED OFF. THE NEEDLE WAS NOT FOUND AND THE PATIENT WENT FOR X-RAYS. THE NEEDLE WAS NOT LOCATED. THE PATIENT FELT NO ADDITIONAL PAIN AFTER THE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366111 BD MICRO-FINE PLUS 31GA PEN NEEDLE PEN NEEDLE, 31G X 8MM FMI BECTON DICKINSON 3241440

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention