BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PRECISION GLIDE NEEDLE

    MDR report key: 1070757 · Received July 1, 2008

    Report

    Report Number
    1911916-2008-00006
    Event Type
    Other
    Date Received
    July 1, 2008
    Date of Event
    June 6, 2008
    Report Date
    July 1, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    PRE-AMEN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPEATED ATTEMPTS WERE MADE TO CONTACT THE REPORTER FOR FURTHER INFO WITHOUT SUCCESS.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A DR CAME TO HER HOUSE AND GAVE HER AN INJECTION IN HER MOUTH WITH A BD NEEDLE. AFTER INJECTION, HER MOUTH WAS SWOLLEN AND DIFFICULT TO OPEN OR SWALLOW. REPORTER INDICATED THAT SHE NEEDED A LARGE AMOUNT OF NARCOTICS FOR PAIN AND THAT THE DR STATED, IT WAS THE NEEDLE THAT CAUSED THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PRECISION GLIDE NEEDLE 18G X 1 1/2" HYPODERMIC NEEDLE FMI BECTON DICKINSON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other