BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFEPICO

    MDR report key: 3820090 · Received May 15, 2014

    Report

    Report Number
    3820090
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 15, 2014
    Manufacturer
    RADIOMETER AMERICA, INC
    Product Code
    CBF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    TECHNICIAN DREW AN ARTERIAL BLOOD GAS ON PATIENT TO ASSESS RESPONSE TO BEING ON BIPAP. AFTER THE SAMPLE WAS OBTAINED, THE NEEDLE WAS REMOVED AND THE CAP PLACED ON THE SYRINGE. THE TECHNICIAN PUSHED THE PLUNGER SLIGHTLY TO EXPEL ANY AIR BUBBLES. THE BLOOD BACKED UP DIRECTLY INTO THE PLUNGER. THE SAMPLE WAS UNUSABLE AND REQUIRED A REDRAW FOR ARTERIAL BLOOD GASES DELAYING PATIENT CARE.======================MANUFACTURER RESPONSE FOR SAFEPICO ARTERIAL BLOOD GASES SYRINGE, SAFEPICO (PER SITE REPORTER).======================AWAITING THE MANUFACTURER'S RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292250 SAFEPICO ARTERIAL BLOOD SAMPLING CBF RADIOMETER AMERICA, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR