Investigation summary: the actual sample was received for the purpose of our investigation, representative samples were also included.The investigators were able to observe the reported failure mode in the actual sample provided, this sample arrived without an adapter and the pvc tubing appeared to not be included in the assembly of the adapter.This issue was not among the representative samples provided.Representative sample was tested and met with acceptance criteria according (b)(4).Additionally the device history report for lot number 6308782 was reviewed, no related abnormalities were found.Material number 383336 for lot 6308782 was manufactured on 11-24-2016.According to the sampling plan applied for product performance, this lot was accepted and released.Investigation conclusion: based on the results of our investigation to date, the root cause is most likely caused by an abnormality occurring during the manual assembly of the device where the pvc was not correctly placed within the wedge.An auto tubing assembly machine is in the process of completing validation for use in the manufacturing line.The inclusion of this machine will greatly mitigate the possibility of reoccurrence for this failure mode.Bd will continue to track and trend for this issue.
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