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.Although no sample has yet been received.Review of a customer provided image appears to show light color in the infusion sleeves.However, without analysis of the samples, we cannot conclusively determine there is a non-conformance, and cannot test the hardness of the material.The color criteria for this sleeve is evaluated, during inspection, and the color was determined to be within the allowable acceptance criteria for this sleeve.The color variation should not impact the intended function of the sleeve.The product was not returned.And therefore, a root cause evaluation could not be performed.No data is available on the hardness of the sleeves.The root cause of the customer's complaint could not be determined conclusively, as the samples were unable to be evaluated.However, the source of the color variation and hardness would originate from the supplier's manufacturing process.This complaint has been reviewed.And the supplier has been made aware of this complaint issue.The supplier has been reviewing their process to ensure greater consistency in sleeve coloration.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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