Qn#(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed, based only on the information provided, to perform a correct investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.An attempt to duplicate the failure mode was made, but at the time there is no inventory of the involved product code (400301;aquapak 301 sw,340 ml,intl) available at the facility nor is being manufactured at the time; however regarding other customer complaints for this same issue, a capa file #(b)(4) was opened to perform a further investigation this issue (this capa is owned by (b)(4)).According to the capa investigation thus far, the root cause for the issue was the positioning of the thread lead and the softness of the new resin used for the snap adaptor.If device sample becomes available at a later date this complaint will be re-opened.
|