No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.A sample has not been returned for this complaint therefore the condition of the product could not be verified.A review of the products bill of materials indicates a blue drape, blue paper towels, and blue gowns are assembled into this pack.When this type of issue occurs, a sample will need to be returned so that a full evaluation can be conducted.Without a sample, we were unable to demonstrate where the blue fiber associated with the event originated.With the available information we were unable to determine the origin of the reported blue fiber.Analysis of the sample could not be performed and no lot information is available, therefore, the root cause for the customer reported event could not be established.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trends and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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