BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRO-VENT PLUS

    MDR report key: 209743 · Received February 9, 1999

    Report

    Report Number
    MW4002419
    Event Type
    Other
    Date Received
    February 9, 1999
    Date of Event
    November 1, 1998
    Report Date
    January 18, 1999
    Manufacturer
    SIMS PORTEX, INC.
    Product Code
    CBT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARTERIAL BLOOD GAS KITS SIMS BRAND CONTAIN IMPERFECT NEEDLES. THE NEEDLES HAVE BENT TIPS AND SNAGGED EDGES, CAUSING TEARING OF SKIN AND SIGNIFICANT INCREASE IN PAIN DURING NEEDLE STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO-VENT PLUS ABG KIT CBT SIMS PORTEX, INC. * 811354
    2 PRO-VENT PLUS ABG KIT CBT SIMS PORTEX, INC. * 811146
    3 PRO-VENT PLUS ABG KIT CBT SIMS PORTEX, INC. * 809499
    4 PRO-VENT PLUS ABG KIT CBT SIMS PORTEX, INC. * 811145

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other