Additional information was added to d9, h3, h4 and h6.H10: the device was received for evaluation.A visual inspection was done which observed an internal obstruction in the spike connector due to molded part.The reported condition was verified.The cause of the condition was due to a failure during the injection molding process of the spike connecter during the manufacturing process.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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