Other, other text: h10 device evaluation: one cadd extension set was returned for investigation in used condition.The sample was visually inspected at a distance of 12 to 16 inches and under normal conditions of illumination.A leak test was performed.A leak was found fleeing from the air vent of the filter in the decontaminated sample.The customer reported product problem was therefore confirmed.The filter leakage was caused by the silicon oil being transferred from the syringes and/or vials into medication reservoir during the filling process by the customer.A user interface issue was therefore established as the root cause.
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