Other, other text: two pictures and one sample were provided for analysis.A leak was found fleeing from the air vent of the filter in the decontaminated sample.The root cause was found to be caused by silicon oil transferred from the syringes and/or vials into the medication reservoir during the filling process by the customer.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
|