BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANAEROBIC PULSATOR BLOOD GAS KIT

    MDR report key: 100903 · Received June 26, 1997

    Report

    Report Number
    1217052-1997-00028
    Event Type
    Malfunction
    Date Received
    June 26, 1997
    Date of Event
    May 1, 1997
    Report Date
    May 28, 1997
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Product Code
    CBT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOSP ALLEGES THAT BLOOD LEAKED PAST THE PLUNGER OF THE SYRINGE WHILE ATTEMPTING TO OBTAIN AN ARTERIAL BLOOD GAS SAMPLE. THERE WAS NO BLOOD EXPOSURE TO THE CLINICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANAEROBIC PULSATOR BLOOD GAS KIT TRAY, BLOOD COLLECTION CBT SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *