Such event is known and generally caused by a failure to comply with the needle-syringe assembly directions, which are mentioned in the instructions for use.The design of the product, with a built-in luer lock and a double screw tread needle-syringe connection, makes needle disconnection/ejection unlikely to occur as long as the user safely screwed the needle onto the syringe.
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The event happened outside of the u.S, in the (b)(6).According to the received information, when using the syringe to inject the patient with the provided needles, the practitioner experienced a needle ejection.No consequence for either the patient or the practitioner was reported.This event is reported considering the possibility that a recurrence of this type of issue can cause a serious injury, despite not being the case here.
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