Date of event: unknown.Investigation summary: one picture sample was received by our quality engineer for evaluation.Through visual inspection of the picture sample, the cannula was observed exposed with the injector grips dislocated.A device history record review was performed for lot number 1704001 and it did not reveal any detected quality issues during the production process that could have contributed to this incident.Injector needles become exposed if they are not properly disengaged, which also results in safety sleeve breakage.It is important to hold onto the white components of the injector when engaging/disengaging; do not grip the blue safety sleeve.If the grips of the safety sleeve become dislocated, the injector is activated causing needle exposure.To avoid damage to the safety sleeve grips, the injector must be removed by pulled it straight back and it cannot be forcefully engaged.It has been determined that this incident most likely occurred due to improper use.Based on the investigation results, it is probable that this incident resulted due to customer misuse.
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