As reported by navilyst medical's distributor in (b)(4), in the distributor's warehouse, a small hole was found in the tyvek portion of the stopcock pouch, breaching the sterility.The device had not been provided to a hosp and was returned to navilyst medical for eval.
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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 lots met all material, assembly and performance specifications.The navilyst medical 03/2015 complaint report was reviewed for the product family of stopcock/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 nipro (the distributor in (b)(4)), all pouched products are removed from their inner boxes and a nipro label (in (b)(4)) is applied to each pouch.Add'l handling may occur if the pouches are 100% visually inspected.The pouched product is then re-boxed into the inner box by the nipro warehouse employees.The hole in the tyvek was likely caused by the handle of the stopcock, however, what caused the handle to be pushed against the tyvek in a manner that resulted in a hole cannot be determined.Potential contributing factors include: over-crowing of filled pouches in the in-process 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 navilyst medical; handling during transit to the nipro warehouse; handling at nipro during the labeling/inspection and re-boxing process.All pouches are 100% inspected per navilyst medical procedures during the sealing and final box processes.The directions for use (dfu) for the stopcocks contain the following warning: "contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged." (b)(4).
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