BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICRO-FINE PLUS 31GA X 5MM PEN NEEDLE

    MDR report key: 3981139 · Received July 23, 2014

    Report

    Report Number
    2243072-2014-00154
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 23, 2014
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    WHEN THE CUSTOMER INSERTED THE NEEDLE INTO HER ABDOMEN, SHE FOUND THE NEEDLE HAD BROKEN OFF AND BELIEVED A PORTION OF THE NEEDLE REMAINED IN HER SKIN. SHE ATTEMPTED TO LOCATE THE NEEDLE USING TAPE, BUT IT COULD NOT BE FOUND. AN X-RAY WAS PERFORMED AND THE NEEDLE WAS NOT LOCATED. THE CONSUMER MET WITH A SURGEON, WHO INFORMED HER THAT A BROKEN NEEDLE MAY NOT BE OBSERVED EVENT THOUGH IT IS IN HER ABDOMEN. THE CONSUMER USED THIS PARTICULAR NEEDLE THREE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432229 BD MICRO-FINE PLUS 31GA X 5MM PEN NEEDLE PEN NEEDLE, 41GA X 5MM FMI BD 3135340

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention