BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL ASD, INC.

    MDR report key: 680658 · Received February 7, 2006

    Report

    Report Number
    MW1037971
    Event Type
    Malfunction
    Date Received
    February 7, 2006
    Date of Event
    February 2, 2006
    Report Date
    February 7, 2006
    Manufacturer
    *
    Product Code
    CBT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PORTEX PRO-VENT (ABG BLOOD SAMPLING KIT). ABG KITS HAVE BEEN FOUND WITH HOLES IN THE SYRINGE THE SIZE OF APPROX A "BB" NEAR THE HUB OR THE END OF THE BARREL NEAR THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMITHS MEDICAL ASD, INC. PORTEX PRO-VENT CBT * * K686983

    Patients

    Seq Age Sex Outcome Treatment
    1 *