Note : product reference 4430018 is not cleared for sales in the usa, but similar product cleared under #510k130576.Batch history review: we have checked the manufacturing file of batch nr36963918 which complies with our specifications and does not present any discrepancy.No other similar complaint has been reported to us on this batch of access ports released in may 2020.Investigation results: we did not received the complaint sample or x-ray films for investigation.Conclusion: without the complaint sample for investigation no thorough investigation is possible and we cannot conclude on the real cause of the incident.If new element become available in the future, we will reopen this complaint.The complaint rate is low (<0,01 %).No corrective action is envisaged at the moment.
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