G4: reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.Summary of investigation: there are no previous complaints of this code-batch.We manufactured and distributed in the market 504 units of this code-batch.There are no units in our stock.We have received an open and unused sample (contaminated) with the thread wound on the pack and the needle detached is missing.However, without closed samples a proper analysis cannot be performed.Taking into account that no other customer complaints have been received concerning this issue for this code-batch, we consider that this is an isolated unit, but the whole batch is correct.Batch manufacturing record: reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Conclusion root cause analysis: it has not been possible to determine the root cause as no closed samples have been received and the sample received is contaminated and a further analysis cannot be performed.Final conclusion: in spite of receiving a defective sample, without closed samples a suitable analysis cannot be performed, and the case is considered not confirmed.Nevertheless, we take note of this incidence and if any closed sample is received in the future, we will re-open the case and analyse it.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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