Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device that is registered within the u.S.(b)(4).Subsidiary received information on (b)(6) 2016, manufacturer was notified of complaint on 08/11/2016 manufacturing site evaluation: evaluation on-going.Device not returned.
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Samples received: none.Analysis and results: there are four previous complaints of this batch.All complaints were closed as not justified after the analysis.(b)(4) units of this batch were manufactured and distributed in the market.There are no units in stock.No samples have been received.Ageing studies were performed with the purpose of provoking the complained defect and study the influence of environmental conditions in its apparition.-ampoules were stressed for 9 days at 40ºc and 30 % rh.After 4 days of exposure, the stress conditions caused the apparition of some polymerization nuclei along the cannula in the ampoules.However, the liquid glue could still pass through the cannula, that was not obstructed.After 9 days of exposure, the polymerization nuclei observed caused the obstruction of the cannula.In conclusion, the environmental conditions influence the apparition of the polymerization nuclei along the cannula.A temperature of 40ºc caused the formation of polymerization nuclei along the cannula and the obstruction of the cannula after 9 days of exposure.Therefore, and according the instructions for use, histoacryl should be stored at ambient temperature below 22ºc.The ampoule containing the adhesive should only be removed from the aluminium pouch immediately prior to application.Final conclusion: without samples we are not in position of studying if the affected product does not fulfil the specifications.In consequence, a proper analysis cannot be done.Nevertheless, we take note of this incidence and if any sample is received in the future, we will re-open the case and analyse it.Please note that when no samples are received our analysis is very limited.Actions on distributed product of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.Corrective/preventive actions: according to internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.
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