BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAVEN FAST FLASH

    MDR report key: 20450747 · Received October 15, 2024

    Report

    Report Number
    3006846316-2024-00001
    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/S BATCH 11T15311 CODE 3811473 TO VERIFY THE CONFORMITY OF THE SAFETY FEATURE AGAINST NEEDLESTICKS INJURIES. 1 - VISUAL INSPECTION OF THE SAFETY FEATURE AIMED AT VERIFYING ITS INTEGRITY, COMPLETENESS AND CORRECT ASSEMBLY OF THE COMPONENTS THAT CONSTITUTE IT SO THAT IT ENGAGES REGULARLY. THE CONTROL REPORT IS AVAILABLE IN ANNEX A AND THE RESULTS OBTAINED ARE INDICATED THEREIN; 2 - CONTROL OF THE NEEDLE OVALIZATION WHICH DETERMINES, BY INTERFERENCE WITH THE DIAMETER OF THE HOLE IN THE SAFETY SPRING, THE ACTIVATION OF THE SAFETY DEVICE THAT COVERS THE TIP OF THE NEEDLE. THE CONTROL REPORT IS AVAILABLE IN ANNEX B AND THE RESULTS OBTAINED ARE INDICATED THEREIN; 3 - DYNAMOMETRIC CONTROL OF THE ACTIVATION OF THE SAFETY FEATURE AND ITS DETACHMENT FROM THE CATHETER BODY FROM WHICH IT IS POSSIBLE TO ESTABLISH WHETHER THE SAFETY DEVICE HAS ACTIVATED REGULARLY AT THE END OF THE EXTRACTION FROM THE NEEDLE. THE CONTROL REPORT IS AVAILABLE IN ANNEX C AND THE RESULTS OBTAINED ARE INDICATED THEREIN; 4 - SAFETY DEVICE EFFICIENCY CHECK CONSISTS IN VERIFYING THAT EVEN WITH REPEATED ATTEMPTS TO REMOVE THE TIP OF THE NEEDLE FROM THE SAFETY DEVICE, THIS DOES NOT LET IT TO COME OUT. THE CONTROL REPORT IS AVAILABLE IN ANNEX D AND THE RESULTS OBTAINED ARE INDICATED THEREIN. ALL THE RESULTS OBTAINED, IN REFERENCE TO THE ABOVE-MENTIONED POINTS CONFIRM THE SUITABILITY OF THE MANUFACTURED DEVICES AND THE ABSENCE OF MANUFACTURING DEFECTS IN THE PRODUCT REFERRED TO LOT 11T15311. SINCE THE DEVICE INVOLVED IN THE INCIDENT IS NOT AVAILABLE, IT IS NOT POSSIBLE TO ESTABLISH EXACTLY THE CAUSE OF THE FAILURE TO ACTIVATE THE SAFETY DEVICE.

    Description of Event or Problem · 0

    I WAS PLACING AN INTRAVENOUS LINE (IV) FOR MY POSITRON EMISSION TOMOGRAPHY (PET) RUBIDIUM PATIENT AND WHEN I GOT BLOOD RETURN AND RETRACTED THE NEEDLE BACK, THE NEEDLE WAS STILL EXPOSED AND DID NOT LOCK WITH THE SAFETY FEATURE, LEAVING THE NEEDLE EXPOSED, ALMOST POKING MYSELF. HIGH SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324420 DELTAVEN FAST FLASH INTRAVASCULAR IV CATHETER FOZ DELTA MED SPA 3811473 11T15311 38032248381149

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown