BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWO-LUMEN INTRAVENOUS SET

    MDR report key: 1001548 · Received February 21, 2008

    Report

    Report Number
    9680794-2008-00003
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 27, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ARRROW INTERNATIONAL INC
    Product Code
    FOZ
    PMA / PMN Number
    K862153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN, THE NURSE WAS STUCK WITH THE NEEDLE WHILE USING THIS PRODUCT. MORE INFO HAS BEEN REQUESTED. ON 2/15/08, RECEIVED REPORT FROM HOSPITAL. THE REPORT STATED, THE NURSE STARTED THE IV AND REMOVED THE STYLUS. AS SHE WAS WALKING TO THE SHARPS CONTAINER, SHE TRIPPED AND NEARLY FELL. THE PARAMEDIC REACHED OUT TO PREVENT HER FALL AND SHE STUCK HIM WITH THE STYLUS IN THE RIGHT MIDDLE FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWO-LUMEN INTRAVENOUS SET PERIPHERAL CATHETER PRODUCTS FOZ ARRROW INTERNATIONAL INC CF7084843

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR