BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA SYRINGE

    MDR report key: 2922139 · Received January 11, 2013

    Report

    Report Number
    1213809-2013-00001
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 8, 2012
    Report Date
    January 11, 2013
    Manufacturer
    BD
    Product Code
    FMI
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RECEIVED TO DATE. THIS DEVICE INCORPORATES A NEEDLE THAT RETRACTS AFTER INJECTION AND IS OFTEN MISTAKEN BY LAY USERS AS THE NEEDLE BREAKING OFF. UNABLE TO RUN COMPLAINT HISTORY CHECK OR DEVICE HISTORY REVIEW AS LOT NUMBER IS UNKNOWN. QUALITY WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT ON (B)(6) 2012, HALFWAY THROUGH INJECTION, THE PLUNGER STOPPED, THE CUSTOMER KEPT PUSHING AND THE SYRINGE BROKE. HE WENT TO THE EMERGENCY ROOM AND HAD AN X-RAY. THE NEEDLE WAS FOUND ON X-RAY. THE EMERGENCY ROOM ADVISED THE CUSTOMER TO LEAVE THE NEEDLE ALONE. CONSUMER EXPERIENCED HOTNESS THE NEXT MORNING AND THOUGHT THE AREA WAS INFECTED. HE WENT TO ANOTHER HOSPITAL AND HAD SURGERY FOR REMOVAL OF THE NEEDLE. THE NEEDLE WAS NOT FOUND. CONSUMER WAS SCHEDULED FOR ANOTHER SURGERY ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18242 INTEGRA SYRINGE HYPODERMIC SYRINGE FMI BD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention