BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31G PEN NEEDLES

    MDR report key: 1082221 · Received July 25, 2008

    Report

    Report Number
    9616656-2008-00006
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 20, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURN IS ANTICIPATED AS COMPLAINT INDICATES THAT THE PRODUCT HAS BEEN DISCARDED. 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 AFTER INJECTING INSULIN THERAPY, NEEDLE REMAINED IN ABDOMEN. CONSUMER WENT TO HOSP AND THE DR DID AN X-RAY AND INCISION, BUT HAS NOT FOUND THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 31G PEN NEEDLES NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON NA 7246085

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R