Investigation: investigation summary: bd requested samples and/or photos of the product, but none were provided by the customer for evaluation.A review of the device history record was completed for the incident lot number and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.A capa was initiated for complaints relating to stopper pop off.The capa investigation is still on-going and further improvements will be made as the potential causes of this issue are identified.Investigation conclusion: a capa was initiated for this issue in order to establish a root cause and implement necessary corrective actions.Root cause description: a capa was initiated for this issue in order to establish a root cause and implement necessary corrective actions.(b)(4).Rationale: based on an assessment of severity and frequency, it was determined that a corrective action (capa) is required at this time.A capa was initiated to determine the root cause associated with stopper pop off and implement corrective actions in order to reduce/mitigate further occurrence of this issue.The capa investigation is currently on-going and further improvements will be made as the potential root cause(s) are identified.
|