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).Manufacturing site evaluation: samples received: 9 unopened pouches.Analysis and results: there are no previous complaints of this code batch.Manufactured and distributed in the market (b)(4) units of this code batch.There are no units in stock.Tested the knot pull tensile strength of the samples received and the results fulfill the oem requirements.Remarks: when working with suture materials great care must be taken to ensure that the use of surgical instruments, such as tweezers and needle holder, does not lead to damage by pinching and kinking.Final conclusion: although the results of the samples received fulfill the oem specifications, note of this incident is taken in order to assess if new or additional actions are needed.Corrective/preventive actions: according to our 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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