BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMITHS PORTEX PRO VENT WITH 2 INCH NEEDLE

    MDR report key: 2172004 · Received August 4, 2006

    Report

    Report Number
    1217052-2006-00053
    Event Type
    Injury
    Date Received
    August 4, 2006
    Date of Event
    July 18, 2006
    Report Date
    August 2, 2006
    Manufacturer
    SMITHS MEDICAL
    Product Code
    CBT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS EVAL: SMITHS MEDICAL ASD, INC. EVAL FOR THIS ISSUE REVEALED THAT THIS EVENT WAS DUE TO DOCTOR HANDING OVER AN EXPOSED NEEDLE AND NOT DUE TO A PRODUCT MALFUNCTION. NO SIMILAR REPORTS HAVE BEEN RECEIVED ON THIS DEVICE CATALOG NUMBER. REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED AS THE USER FACILITY DID NOT RECORD THE DEVICE LOT NUMBER. THE INSTRUCTIONS FOR USE STATE: 4.4 DO NOT EVER ATTEMPT TO PLACE NEEDLE INTO POINT-LOK DEVICE WHILE HOLDING THE DEVICE. THIS MAY RESULT IN AN ACCIDENTAL NEEDLE STICK INJURY. AND 4.5 USE THIS DEVICE ONLY ON A FLAT, SECURE, STURDY SURFACE WHEN ATTEMPTING TO ENGAGE NEEDLE IN THE POINT-LOK DEVICE. ATTEMPTING TO DO OTHERWISE COULD POSSIBLY LEAD TO A CONTAMINATED NEEDLE STICK.

    Description of Event or Problem · 1

    ADDITIONAL INFO FROM THE USER FACILITY REPORT: EMPLOYEE INVOLVED IN EMERGENCY SITUATION. DOCTOR DREW ARTERIAL BLOOD GASES AND HANDED AT OFF - TWO PEOPLE GRABBED FOR CAPPING DEVICE AND ONE GOT POKED WITH NEEDLE. REQUIRED TETANUS SHOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITHS PORTEX PRO VENT WITH 2 INCH NEEDLE ABG KIT/NEEDLE CBT SMITHS MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention