Summary of investigation: there are no previous complaints of this code-batch of which we manufactured and distributed in the market (b)(6) units.There are no units in our stock.We have received (b)(6) closed samples for analysis.Tightness test to the closed samples received has been performed and the units are tight.We have tested the needle attachment strength of the closed samples received and the results fulfil the requirements of the european pharmacopoeia (ep requirements: 0.23 kgf in average and 0.11 kgf in minimum).The results are: 0.86 kgf in average and 0.26 kgf in minimum.Batch manufacturing record: reviewed the batch manufacturing record, this product had no incidences related to this issue and was released fulfilling usp/ep and b.Braun surgical specifications.Furthermore, needle attachment results conducted on samples before releasing the product were 0.85 kgf in average and 0.75 kgf in minimum and fulfilled ep requirements.Conclusion root cause analysis: it has not been possible to determine the root cause because the closed samples received comply with usp/ep and b.Braun surgical requirements.Final conclusion: although the results of the closed samples received fulfil european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.The case is considered not confirmed by evidence of the samples received.Corrective measures: actions on product distributed 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 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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