The custom pak lot specific to this event is not known; therefore, lot history and device history reviews are not possible.A sample has not been returned for this complaint; therefore, visual inspection could not be performed.Additionally, the customer did not provide any details describing the type of fiber found.This file will be processed for closure and opened at a later date if a sample is returned.The customer's pack was reviewed and various sources were identified as potential contributory factors to fibers for example, gowns, drapes, towels, sponge gauze, eye spears and the back table cover.The root cause of the customer's complaint is not known; a sample was not returned for investigation.An action has been opened to document the investigation and associated corrective action(s) related to custom pak contamination.(b)(4).
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