Note: product reference 4430433 is not cleared for sales in the usa, but it is similar to the product reference 5430425 cleared under #510k130576.Batch history review: we have checked the manufacturing file of batch nr m3329150 which complies with our specifications and does not present any discrepancy.The sterilization records does not present any abnormality.No other complaint has been reported to us on this batch of 77 access ports released in december 2013.Investigation results: we did not receive the complained sample for investigation, nor the x-ray pictures.Conclusion: we think that the detection of staphylococcus bacteria could be explained by the exteriorization of the port.However, without any element for investigation (complained sample, x-ray pictures), no thorough investigation is possible and we cannot conclude on the real cause of the exteriorization of the access port.It is worth noting that several factors can contribute to this exteriorization occurred 4 years after the implantation: too superficial implantation of the port (must be between 5-10 mm below the skin surface), the patient may lose weight with time, and the port becomes too superficial; incision over the port septum (can weakened the skin); leakage of product from the port, especially chemotherapy drugs (may be due to needle not stabilized, needle not in the septum, use of non huber type needles, etc); infection; radiation over the port site (leads to fragile skin).This is a rare incident.No corrective action is currently envisaged.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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