Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, trends and a visual inspection/functional test of the returned device were conducted during the investigation.Clinical assessment: prior to catheter, the ifu states, ¿flush catheter with heparinized saline solution or sterile water.¿ if the device was unable to be flushed it potentially could cause a delay in procedure resulting in minor harm.At this time the most probable cause of this event is manufacturing related.The visual inspection of the returned device confirmed one unopened package containing a catheter set was returned for investigation.The complaint device was not returned for investigation.The catheter was wired with the tuohy borst adaptor attached without issue.The tuohy borst adaptor was removed.Upon removal, a circular piece of plastic material fell out.The lumen was wired again with wire guide from set without issue.A functional test was performed by flushing the catheter with water.Initially the catheter would not flush, then a small cluster of plastic material pushed out of lumen and then the water flushed through the lumen.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there was one other reported complaint for this lot number.Based on the information available the other complaint is considered unrelated to the current complaint.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
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