A review of the device history records was performed for the reported packaging lot 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 (b)(4) 11/2015 complaint report was reviewed for the product family of stopcocks/manifolds and the failure mode, 'hole in pouch.' no adverse trends were identified.The returned sample was visually inspected and the hole in the pouch was confirmed.As part of the receiving process at (b)(4) (the distributor in (b)(4)), all pouched products are removed from their inner boxes and a (b)(4) label (in (b)(4)) is applied to each pouch.Additional handling may occur if the pouches are 100% visually inspected.The pouched products is then re-boxed into the inner box by the (b)(4) warehouse employees.The hole in the (b)(6) was likely caused by the handle of the stopcock, however, what caused the handle to be pushed against the (b)(6) in a manner that resulted in a hole cannot be determined.Potential contributing factors include: handling in the inprocess bins after sealing but prior to being sent to the final box area or handling of the pouches as they are placed in the inner boxes at (b)(4).Handling during transit to the (b)(4) warehouse.Handling at (b)(4) during the labeling/inspection and re-boxing process.All pouches are 100% inspected per (b)(4) procedures during the sealing and final box process.(b)(4).
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