Note: product reference 4433750 is not cleared for sales in the usa, but it is similar to the product reference 5433750 cleared under # 510k130576.Batch history review: we have checked the manufacturing file of batch nr 36987931 which complies with our specifications and does not present any discrepancy.A similar complaint has been reported to us by the same end user (9612452-2022-00031) on this batch of access ports released in december 2021.Investigation results: despite requests, we did not receive the complaint sample or the x-ray pictures for investigation.Conclusion: without the complaint sample or the x-ray pictures 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.This is a rare incident (<0.01%), no corrective action is envisaged for the moment.
|