BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31G X 5MM PEN NEEDLE

    MDR report key: 2190439 · Received July 28, 2011

    Report

    Report Number
    9616656-2011-00022
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K110105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW WAS CONDUCTED AND NO ANOMALIES NOTED. AWAITING ADDITIONAL INFORMATION OF PRODUCT EVALUATION. WILL SUBMIT A SUPPLEMENTAL REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    COMPANY REPRESENTATIVE REPORTED NEEDLE BREAK OFF DURING INJECTION IN PATIENT'S ABDOMEN. PATIENT WAS AT THE HOSPITAL FOR SURGERY TO TRY AND REMOVE NEEDLE BUT THE BROKEN NEEDLE COULD NOT BE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 31G X 5MM PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON NA 0008602

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R