Investigations: visual inspection.The following observations were made during the visual inspection: - catheter ruptured, traces of tears are visible - yellowish discoloration of the catheter permeability test: the test showed that the two parts of the peritoneal catheter are permeable.During the test flushed out some particles.Results: based on our investigation, we are able to substantiate the claim of "fractured catheter".At the time of the investigation, it is not clear to us how the mentioned functional impairment occurred.We can exclude the possibility of a defect at the time of release.Our peritoneal catheters are tested to 100 % elongation.After the elongation, a constant deformation of 7 % is acceptable.All products met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.From our point of view, no further regulatory actions are required.
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