A review of the device history records was performed for the reported packaging lot for item number h965914004001 for any deviations related to the reported defect of the complaint.The review confirms that the lot met all material, assembly and performance specifications.The recent angiodynamics complaint report was reviewed for the y-adaptor product family and the failure mode "seal compromised".No adverse trend was indicated.Based on the sample supplied from the customer, the customer's complaint for "improper seal (seal compromised) is confirmed.The tip of the introducer sheath protector was sealed in the closure seal area of the pouch causing the seal to become compromised.The root cause is that responsible employees did not seal the pouch correctly and properly visualize per angiodynamics' procedures.Packages are 100% visualized for this type of non-conformance and the employees who packaged the lot in question did not identify the non-conforming units during their inspection.In an effort to heighten awareness of the performance of our products in the field, recent complaints have been reviewed in a weekly meeting with the entire department.All employees associated with the issue have been retrained on the applicable packaging and inspection procedures.((b)(4)).
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As reported by angiodynamics' distributor in (b)(4), in the distributor's warehouse a compromised pouch seal was found on a guidewire introducer pouch, thereby breaching sterility.The pouch had not been provided to a hospital and was returned to angiodynamics for evaluation.
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