BEUDAMED
    FDA Adverse Event Other Summary report: N

    PORTEX PRO-VENT

    MDR report key: 692032 · Received March 9, 2006

    Report

    Report Number
    692032
    Event Type
    Other
    Date Received
    March 9, 2006
    Date of Event
    January 28, 2006
    Report Date
    March 9, 2006
    Manufacturer
    PORTEX, INC.
    Product Code
    CBT
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A C-SECTION, RN OBTAINED ARTERIAL AND VENOUS BLOOD GASES USING PORTEX PRO-VENT ARTERIAL BLOOD SAMPLING KITS. IT TOOK A GREAT DEAL OF PRESSURE TO ACTIVATE THE NEEDLE COVER. BOTH TIMES SHE NEARLY BROKE THE THE NEEDLE BEFORE THE DEVICE CLICKED OVER THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTEX PRO-VENT SYRINGE, SAFETY DEVICE CBT PORTEX, INC. * K706661

    Patients

    Seq Age Sex Outcome Treatment
    1 *