Note: product reference 4433742 is not cleared for sales in the usa, but it is similar to the product reference 5433742 cleared under #510k 130576.Batch history review: the manufacturing file was reviewed.It is compliant with our specifications and no abnormality was detected.No other similar complaint was reported on this batch of access ports.Investigation: despite several requests, either the involved device nor the x-ray pictures were returned for analysis.Conclusion: without the device for evaluation, no conclusion can be drawn concerning the cause of the catheter rupture.Catheter rupture is a known risk of access port implantation, indicated as a potential complication in the ifu.No corrective action is envisaged as this type of incident is rare.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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Note: product reference (b)(4) is not cleared for sales in the usa, but it is similar to the product reference (b)(4) cleared under #510k130576.Investigation results we received for investigation celsite babyport access port involved in the event.The 13.8 cm long catheter is still connected the access port housing with the connection ring.The catheter is cracked at 5 cm of the port housing.As the catheter is slacked around the crack, this means that the crack is due to catheter burst at this level.This means that a high pressure was applied in the system.The catheter dimensionally complys with the specifications.Conclusion: the evaluation of the explanted device did not allowed us to detect any manufacturing defect on the device.The catheter burst observed probably results from the fact that excessive pressure has been applied during the injection while the catheter was obstructed by an external element (drug crystallisation, thrombus, fibrin sleeve,.).The ifu specify to always verify that the port is functional by aspirating blood then injecting nacl before attempting to start an infusion and give some advices to avoid occlusion of the system and to avoid generating excessive pressures in case of occlusion of the system.It is an isolated case.No manufacturing defect has been detected on the returned sample, consequently no corrective action is envisaged.
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