Results: three sample units were received for evaluation by our quality engineer team.Upon examination, all three units were open at the top of the blister pack.The packages were analyzed under uv light, as the adhesive used is uv fluorescent.The uv analysis revealed an adequate amount of top web adhesive.A functionality test resulted in a successful retraction of the needle, with no signs of mechanical or physical damage that could contribute to the reported issue of needle retraction failure.Although the defect of package seal integrity poor was confirmed, since no physical evidence was found to support manufacturing process related issues, a root cause could not be determined.Proper personnel have been notified of these issues for further review.A review of the device history record revealed no irregularities during the manufacture of the reported lot number.The defect package seal integrity poor/questionable, as stated in the description of the complaint was confirmed with the returned unit.Even though the package was partially opened, all the processes characteristics that directly influence the seal strength were observed to be within specification.No anomalies were found.The defect of needle retraction failure as stated as the reported coded was not confirmed with the returned units.No physical mechanical evidence was found to trigger the failure and the unit successfully retracted upon activation of the white button.The root cause is indeterminate.Refer to (b)(4).
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