Samples received: 1 open pouch.Analysis and results: there are no previous complaints of this code batch.Manufactured (b)(4) units of this code batch.There are (b)(4) units in stock.Received one open and used sample with the thread broken near the needle attachment (approximately 1 cm to the needle attachment).Without any closed samples an analysis can not be performed in order to make a decision.Twelve units of stock for analysis was requested.Tested the knot pull tensile strength of the samples of stock and the results fulfill the oem requirements.Tested the needle attachment of the samples of stock and the results fulfill the oem requirements.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill the oem requirements.Remarks: "when working with suture materials great care should be taken to ensure that the use of surgical instruments, such as forceps and needle holders, do not cause any crushing or crimping damage to the suture material".Final conclusion: although the results of the samples of stock 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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