Note: product reference 4430425 is not cleared for sales in the usa, but its catheter is similar to the product reference 5430425 cleared under #510k130576.The manufacturing file was reviewed.It is compliant with our specifications and no abnormality was detected.No other complaint was reported on this batch of access ports.Investigation results: the access port involved in this incident has been returned for evaluation but the catheter is not available for analysis.No visible defect has been detected on it.The access port is dimensionally compliant with the specifications.A disconnection test has been performed on the returned access port with a catheter from the same batch.The disconnection force is more than 4 times superior to the requirement.Conclusion: the returned access port presents no failure and is compliant with the specifications.The incident was discovered only 1 month after the implantation.No other incident was reported on the access ports batch.This information allows us to deduce that the catheter disconnection is probably due to incorrect catheter/port connection.The ifu's specify how to connect the catheter to the access port and the risks of incorrect connection.B braun sas 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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