BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31G X 5MM BD PEN NEEDLE

    MDR report key: 2151536 · Received June 27, 2011

    Report

    Report Number
    9616656-2011-00018
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED. COMPLAINT HISTORY CHECK YIELDED NO OTHER COMPLAINTS FOR SIMILAR CONDITION FOR THE LOT REPORTED. NO OBVIOUS TRENDS WERE NOTED. DEVICE HISTORY REVIEW WAS CONDUCTED AND NO ANOMALIES NOTED. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CONSUMER REPORTED HIGH BLOOD SUGAR DUE TO NOT GETTING HER INSULIN. SHE ALSO REPORTED CLOG NEEDLES. SHE CONSULTED WITH HER MD WHO SAID SHE IS NOT GETTING HER INSULIN. SHE RECEIVED IV AT HOSPITAL TO HELP LOWER HER BLOOD SUGAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 31G X 5MM BD PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON NA 9336861

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R