Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: no.As a lot number was not provided for this incident, a production history record review could not be completed and retained samples could not be investigated.Since no picture samples or physical samples were available, a thorough sample investigation could not be completed.Needle exposure occurs when the safety sleeve is damaged.Safety sleeve breakage occurs when the injector is not properly engaged/disengaged.It is important to hold onto the white components of the injector when engaging and/or disengaging the device; and not touch the blue safety sleeve.If the grips of the safety sleeve are dislocated, the injector is activated and the needle is exposed.When disengaging the injector, the device must be removed by pulling straight back to avoid grip damage.If the injector has been forced while engaging, the grips may also become damaged.It is important to follow the instructions for use carefully when using the phaseal injector product.As it is explained the breakage occurs when the injector is not properly disengaged.User error.
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