The potential lot affected is lot number 18050137.The review of the manufacturing batch record of the polysite 4018pi implantable port final product (lot 18050137) did not highlight any deviation that could be the root cause of the incident.Indeed, the sealing of the port-catheter-connection ring assembly is verified on 100% of the devices manufactured by injecting air at a pressure of 2.2 bar +/- 0.2 bar for 1 minute.Alteration of the catheter or connecting ring would most likely have led to a leakage and would have been detected.The leak test performed on the (b)(4) units manufactured is in accordance with the specifications.No deviation was detected.The device is in transit for returned to perouse medical.Perouse medical hasn't been informed of other incidents implying the batch 18050137 (potential lot).We asked more information about the incident (date implantation, date explantation, venous access routes, implantation and explantation reports, copy of x-ray pictures for implantation and observation of event, the consequences for the patient).We are waiting for the device in order to perform a technical investigation.
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