Additional information provided in d.9., h.3., h.6., and h.10.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The customer reported that the infusion auto infusion valve (aiv) filter was broken in their pak.One used pak was visually inspected.The housing of the auto stopcock fell apart.The top and base auto stopcock housing appeared to have been insufficiently welded.The root cause of the customer's complaint was determined to be related to equipment not maintaining consistent control of the weld process.Contributing factors identified were training issues during production when performing the integrity squeeze check on the component to verify a good weld and when performing maintenance on the equipment.Action was taken to determine root cause and to take appropriate corrective actions for complaints of a similar nature.Quality assurance identified the likely contributors to be related to equipment end of life and will be replaced with a new system.Procedural enhancements were also implemented for better control of process during quality checks and for better training of personnel during production and equipment maintenance.Complaints are reviewed and monitored at regular intervals for adverse trends.No further action has been identified for this reported event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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