BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX SPINAL 25 GAUGE WHITACRE

    MDR report key: 1010166 · Received February 8, 2008

    Report

    Report Number
    1010166
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 8, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    ANESTHESIOLOGIST INJECTED PATIENT WITH BUPIVACAINE HCL 0.75% IN DEXTROSE 8.25%. SENSORY EFFECT WAS ACHIEVED, BUT NOT MOTOR EFFECT.ANESTHESIOLOGIST STATES THAT THIS IS THE THIRD SUCH CASE IN THE PAST MONTH OR SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX SPINAL 25 GAUGE WHITACRE TRAY, SPINAL CAZ SMITHS MEDICAL ASD, INC. * 1242942

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR OTHER| OTHER