Investigation summary: a review of the device history record revealed no irregularities during the manufacture of the reported lot # 6243978.One used unit and seven unused units were received for analysis.Our quality engineer visually inspected the used unit and confirmed that the needle had separated from the stylet.This product is assembled manually and this defect is related to an incorrect placement of the stylet into the needle.7 representative samples were functionally tested, all these samples met with acceptance criteria after perform pull test between needle/ stylet.Needle/ stylet (pull test): average: 14.95 pounds, minimum: 13.82 pounds, maximum: 15.67 pounds, specification: 9.0 pounds (minimum).Investigation conclusion: based on evaluation (used unit), we can confirm and associate the defect to manufacturing process.
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