(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 for evaluation.No photo for review.The device history record of batch number 74j1601377 that belong to catalog number 1734 (up-draft ii opti-neb nebulizer w/reserv)has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided, in order to perform a proper investigation it is necessary to evaluate the sample involved in the incident.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code and it is not being manufactured at the time.If the device sample becomes available this investigation will be updated with the evaluation results.
|