The involved sample is not available for evaluation.However, unused samples were returned by the user facility for evaluation.Therefore, the investigation was based upon evaluation of user facility information, retained samples, returned unused samples and quality records.Visual inspection of returned unused samples and retained samples did not reveal any defects or abnormalities.Function testing on the returned unused samples and testing of the reserve samples confirmed that performance specifications were met.A review of the device history record confirmed that there were no production related problems for this lot number.A review of the complaint files confirmed that this lot number has not been reported previously.Although the cause for the reported event cannot be definitively determined based on the available information, there is no indication that the event was related to a pre-existing device defect.The device labeling does address the potential for such an occurrence in the instructions-for-use with statements such as the following: "keep hands behind the needle at all times during use and disposal".All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending, and follow-up.(b)(4).
|