(b)(4).Manufacturing site evaluation: samples received: 36 unopened pouches.Analysis and results: there are no previous complaints of this code batch.Manufactured (b)(4) units of this code batch, there are no units in stock.Tightness test to the samples received has been performed and the units are tight.Tested the knot pull tensile strength of the samples received and the results fulfill the requirements of the oem.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Remarks: as indicated in the instructions for use of the product: "when working with monoplus® suture material, great care should be taken in order to ensure that the surgical instruments used, such as forceps or needle holders do not cause any crushing or crimping damage to the suture material.Final conclusion: although the results of the closed samples received fulfill the specifications of oem requirements, note is taken of this incidence in order to assess if new or additional actions are needed.We regret any inconvenience this issue may have caused and thank you for your collaboration.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to take actions in distributed product.The customer will receive a credit note for one boxes of product for the units sent.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.
|