Evaluation summary: one sample was received and a visual inspection was conducted.It was observed that the flange was detached from the cannula and it was noticed the flange and the right and left hole of the cannula present damage, which would have been detected immediately in the manufacturing process since that defect is extremely obvious.The failure mode is not confirmed as related with the manufacturing process.Additionally, a dimensional test was performed to the outer cannula holes and flange lug pin and all the readings are according to specification.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
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