BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-VENT ARTERIAL BLOOD GAS SAMPLING KIT

    MDR report key: 88137 · Received May 2, 1997

    Report

    Report Number
    1217052-1997-00019
    Event Type
    Malfunction
    Date Received
    May 2, 1997
    Date of Event
    March 1, 1997
    Report Date
    April 2, 1997
    Manufacturer
    SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
    Product Code
    CBT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A.3. SEX OF PATIENT IS NA. PLEASE NOTE THAT THE PATIENT INFO THROUGHOUT THIS SECTION IS NA BECAUSE NO PATIENT INVOLVEMENT WAS REPORTED FOR ANY OF THE ALLEGED EVENTS. D.7 AND D.8. SINCE THE DEVICE INVOLVED IN THIS EVENT WAS NOT IMPLANTED, NO ENTRY IS REQUIRED FOR EITHER OF THESE SECTIONS. ENTIRE SECTION F: SINCE THIS REPORT IS FOR A PRODUCT PROBLEM AND NOT AN ADVERSE EVENT, NO ENTRY IS REQUIRED THROUGHOUT THIS SECTION.

    Description of Event or Problem · 1

    THE HOSPITAL ALLEGES SEVERAL EVENTS OF BLOOD LEAKAGE PAST THE PLUNGER OF THE BLOOD GAS SYRINGE. THERE WAS NO REPORTED BLOOD EXPOSURE FOR ANY OF THE ALLEGED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRO-VENT ARTERIAL BLOOD GAS SAMPLING KIT TRAY, BLOOD COLLECTION CBT SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. NA 702061,702550

    Patients

    Seq Age Sex Outcome Treatment
    1 *