We contacted the customer and asked for more details about the incident.The customer has informed us that there is no defective product to return, and no further details can be provided about the insertion site or the device problem and why the port had to be removed, other than as stated in the incident description.As a result, this complaint could not be confirmed, and the root cause of the issue cannot be established.The most likely hypothesis that could explain the externalization phenomenon from the implantable port could be: · the use of an implantable port not adapted to the patient's morphology (dimension (too large), material, indication.An implantable port located less than 1 cm from the skin.Weight loss of the patient, the weakening of the patient's skin by chemo products.Unfortunately, without additional information and regarding our investigation, it is not possible to confirm these hypotheses.The review of the manufacturing batch record of the polysite 3017spi implantable port final product (lot 22090085) did not highlight any deviation that could be the root cause of the incident.Perouse medical has been made aware of two similar incidents involving this lot 22090085, both reported from the same hospital center.Perouse medical has not recorded similar incidents of port externalization between 2020 and 2023 across all its implantable catheter ports.On the other hand, we have been informed of four similar incidents in 2024 occurring in the same hospital.Corrective action: due to the missing sample and further information this complaint could not be confirmed, and the root cause of this issue cannot be established.Therefore, no further corrective action was initiated by quality management.
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