BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FMF-DISP. SYRINGES AND HYPODERMIC NEEDLES

    MDR report key: 2383730 · Received December 15, 2011

    Report

    Report Number
    1038445-2011-00001
    Event Type
    Injury
    Date Received
    December 15, 2011
    Date of Event
    October 1, 2011
    Report Date
    November 17, 2011
    Manufacturer
    EXEL INTERNATIONAL INC.
    Product Code
    FMI
    PMA / PMN Number
    K861153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REFERENCED IN THIS MEDWATCH WAS A COMPONENT CONTAINED WITHIN CENTURION MEDICAL PRODUCTS' CONVENIENCE KIT MANUFACTURED FOR CORE INSTITUTE (PRODUCT CODE MNS6645, LOT# 2010060150). COMPLAINT DEVICE WAS SENT TO (B)(4) FOR FURTHER EVAL.

    Description of Event or Problem · 1

    THE PHYSICIAN PERFORMED AN INJECTION ON A PT AND EXPERIENCED SOME RESISTANCE WHEN REMOVING THE NEEDLE. ONCE THE NEEDLE RELEASED, HE NOTICED THE HUB OF THE NEEDLE WAS STILL ATTACHED TO THE SYRINGE, BUT NOT THE NEEDLE SHAFT. THE NEEDLE APPEARED TO HAVE BROKEN OFF AT THE BASE OF THE HUB, AND THE NEEDLE SHAFT REMAINED INSIDE THE PT. THE PHYSICIAN AND HIS PARTNER ATTEMPTED TO REMOVE THE BROKEN NEEDLE, BUT FELT THE NEEDLE SHAFT APPEARED TO BE MOVING DEEPER INTO THE PT. HE MADE THE DECISION TO STOP THE REMOVAL ATTEMPT AND HAVE THE NEEDLE REMOVED SURGICALLY. WITHIN AN HOUR, THE PT WAS TRANSFERRED TO (B)(6) HOSPITAL WHICH IS DIRECTLY ACROSS THE STREET FROM THE (B)(6), WHERE THE INCIDENT OCCURRED. THE NEEDLE WAS SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMF-DISP. SYRINGES AND HYPODERMIC NEEDLES FMI EXEL INTERNATIONAL INC. 26427 09H05

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention