BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAVEN FAST FLASH

    MDR report key: 20450744 · Received October 15, 2024

    Report

    Report Number
    3006846316-2024-00002
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    June 1, 2024
    Report Date
    July 1, 2024
    Manufacturer
    DELTA MED SPA
    Product Code
    FOZ
    UDI-DI
    38032248381149
    PMA / PMN Number
    K200373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WITH REFERENCE TO REPORT FDA # (B)(4) WE HAVE COLLECTED FROM OUR WAREHOUSE N. 3 STERILE DEVICES OF THE SAME LOT OF DELTAVEN Y DNL G24X19MM BATCH 11T15311 INVOLVED IN THE INCIDENT. I - TESTS PERFORMED ON N. 3 DELTAVEN Y DNL G24X19MM BATCH 11T15311 CODE 3811473 TO VERIFY THE DISPLACEMENT AND MALFUNCTION OF THE DEVICE. 1) LEAKAGE TEST PERFORMED AT A PRESSURE GENERATED BY A COLUMN OF FLUID 400+/- 10MM HIGH FILLED IN WITH SIMULATED BLOOD TO SIMULATE THE USE OF THE CATHETER AND VERIFY THE LEAKAGE AT LOW PRESSURE OF ALL ITS COMPONENTS FROM THE ACTUAL INTRAVENOUS CATHETER UP TO THE FINAL VENT FITTING, INCLUDING THE ASSEMBLED NL VALVE. DURING THE EXTRACTION OF THE NEEDLE FROM THE CATHETER, THE CORRECT ACTIVATION OF THE SAFETY DEVICE DESIGNED TO PROTECT THE OPERATOR FROM ACCIDENTAL NEEDLE STICKS INJURIES HAS BEEN CHECKED. THE TEST REPORT IS PROVIDED IN ANNEX A. 2) HIGH PRESSURE LEAK TEST PERFORMED AT 23 BAR (330 PSI) TO VERIFY WHETHER THERE ARE MICRO CRACKS IN THE DEVICE THAT CAUSE LEAKS THAT ARE EASILY DETECTABLE AT HIGH PRESSURE. TEST REPORT IS PROVIDED IN ANNEX B. BASING ON THE CHECKS PERFORMED AND ABOVE DOCUMENTED ON THE DEVICES OF THE SAME BATCH INVOLVED IN THE INCIDENT, NO MANUFACTURING DEFECTS WERE IDENTIFIED THAT COULD HAVE CAUSED LEAKS FROM THE FITTINGS AND THE DEVICE AS A WHOLE. WITH THESE TESTS, ANY SERIAL DEFECT IS CERTAINLY EXCLUDED. SINCE THE DEVICES INVOLVED IN THE INCIDENT IS NOT AVAILABLE, WE ARE NOT ABLE TO ESTABLISH EXACTLY THE CAUSE OF THE LEAK EVEN WITH MULTIPLE REPLACEMENTS OF THE NL VALVE.

    Description of Event or Problem · 0

    THE SAFETY HUB HAS A CRACK IN IT AND WAS LEAKING. I SWITCHED OUT 3 DIFFERENT (INCLUDING THE ONE THAT CAME WITH THE INTRAVENOUS LINE (IV) SET) MICROCLAVE CONNECTORS., BUT THE LEAKING CONTINUED. SINCE I WAS GOING TO BE INJECTING A RADIOACTIVE DOSE, I COULD NOT USE THIS IV BECAUSE I DID NOT WANT RADIOACTIVITY TO LEAK OUR THE IV. SO I HAD TO START ANOTHER IV ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324417 DELTAVEN FAST FLASH INTRAVASCULAR IV CATHETER FOZ DELTA MED SPA 3811473 11T15311 38032248381149

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown