BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ECLIPSE

    MDR report key: 3060292 · Received April 11, 2013

    Report

    Report Number
    2243072-2013-00025
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE EMPLOYEE WAS DOING BLOOD WORK ON A PATIENT AND WAS EXPLAINING THE PROCEDURE. WHEN EMPLOYEE PUT THE NEEDLE IN THE PATIENT'S ARM, PATIENT BECAME EXTREMELY AGGRESSIVE AND STARTED SHAKING HIS ARM AND TRYING TO PUNCH EMPLOYEE WITH THE OTHER ARM DURING THE PROCEDURE. EMPLOYEE LOST CONTROL OF THE NEEDLE AND EXPERIENCED A NEEDLE STICK ON THE LEFT HAND POINTER FINGER. EMPLOYEE WAS WEARING GLOVES. THE NURSE THEN CAME IN TO HELP THE EMPLOYEE, TO CALM PATIENT DOWN AND TAKE THE TOURNIQUET OFF. EMPLOYEE WASHED HER HANDS IMMEDIATELY WITH SOAP AND WATER. EMPLOYEE ASK IF SHE NEEDED ASSISTANCE WITH THE PATIENT AND SHE SAID NO. ADDITIONAL INFORMATION RECEIVED VIA E-MAIL ON (B)(6) 2013, THE EMPLOYEE WAS SEEN BY A DOCTOR AND ANTI-RETROVIRAL MEDICATIONS WAS PROVIDED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156519 BD ECLIPSE 21G X 1.25 IN BLOOD COLLECTION NEEDLE FMI BD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention