Note: product reference 4430092 is not cleared for sales in the usa, but similar product reference 5430095 is cleared under #510k130576.Batch history review: we have checked the manufacturing file of batch nr m0788990 which complies with our specifications and does not present any discrepancy.Another similar complaint, from the same end customer has been reported to us on this batch of access ports released in april 2013.Investigation results: we did not received the complaint sample for investigation.We received a picture of a "v" type catheter tip, we can see a that the ended valve is missing.X-ray pictures review: we received a ct scan picture.On this picture, we can see a 12mm long piece at the level of the lung.We can hypothesis that this is the catheter valve.Conclusion: the complaint is confirmed, the valve has been disconnected from its catheter.However, without the device for investigation, no thorough investigation is possible and we cannot conclude on the real cause of the valve disconnection.A capa has been implemented in production in september 2018 in order to reinforce the valve holding on the catheter.The batch number involved in the complaint has been manufactured prior to this capa.No further corrective action is envisaged at the moment.B braun (b)(4) has provided all the information currently available to us.In spite of all reasonable efforts being made to obtain further information or the device, at this time we have not met with success.
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