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The DropSafe™ Sicura™ are sterile, single-use passive safety injection needles to be used in combination with a (pre-)filled syringe for subcutaneous and intramuscular injection.

DropSafe™ Sicura™ are Sterile, single-use passive safety injection needles to be used in combination with a (pre-)filled syringe for subcutaneous and intramuscular injection. DropSafe™ Sicura™ are single patient and used by HCP (Healthcare professionals: nurses, pharmacist and physician). DropSafe™ Sicura™ passive safety injection needles, are hypodermic needles intended for subcutaneous and intramuscular injection of fluids using syringes with male luer slip or luer lock fitting. Passive safety injection needles are equipped with passive sharps prevention feature. They are sterilized with ETO. Non-toxic single use, single patient devices. The device is designed to minimize the risk from accidental needle sticks with an already used needle by application of a sharps injury prevention feature. Following use, the slider of the needle is automatically locked out preventing reuse. The needle is protected by an external cover, the cover must be in place during the connection between the needle and the syringe. After removing the external cover the needle is still protected by a transparent slider, the slider will protect the needle and the user during the injection activity (sharp prevention feature). The slider is transparent for allowing the user to have a clear view of the cannula during the injection. During the injection the slider progressively uncovers the cannula; this action is possible thanks to the presence of two components (spring and sleeve) which let the slider moves up and down. Once the injection is done and the needle removed from the slider automatically covers the cannula and remain blocked, guaranteeing the sharp prevention feature. The confirmation about the blocking is done thanks to the appearing of red marks visible through the housing. DropSafe™ Sicura™ is not intended to be used for the drawing up of drugs from vials and/or ampule, for which it's indicated to use blunt needles. Each DropSafe™ Sicura™ is individually packaged in a sealed container. The DropSafe™ Sicura™ is used by opening the blister and applying the needle on a syringe filled with drug. While inserting the needle into the skin at a 90° or 45° angle (with or without skin fold), the slider glides into the housing. While the slider glides into the housing, the safety feature is activated. Following injection, the slider glides back into its initial position, completely covering the needle where it remains locked. The red safety lock indicator tells the user that the safety lock has been activated. Once the DropSafe™ Sicura™ is in the locked mode, it cannot be reused. The DropSafe™ Sicura™ is detached from the syringe and disposed of into a sharps container according to local requirements. The DropSafe™ Sicura™ assembly consists of a cannula that is assembled into an injection molded hub using an UV glue. The hub has been designed in order to guarantee a proper connection with luer lock and luer slip nozzle of syringes. The cannula is lubricated using a silicone-based lubricant for ease of injection and thus reduce friction during the injection. The other components that are assembled onto hub/cannula components are stainless steel spring, injection molded housing, sleeve with red coloured stripes and slider. The coupling of spring, sleeve and slider let have the safety prevention feature of the device, avoiding accidental needle-sticks. This needle assembly is inserted into a protective injection molded cover and blistered with a peel away medical grade paper which provides a sterility barrier.