Additional information in device evaluated by mfr?, evaluation codes and additional mfr narrative.A device history record review for the reported lot indicates that the order was built to specification.The drawing for this pack was reviewed and the drapes, sponge gauze, mayo stand cover, cotton tip applicators, eye spears, eye pad, and instrument wipe were identified components in this pack that could contribute to lint and fibers.It was also noted that the sponge gauze is placed in the emesis basin.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 root cause of the complaint is not known; a sample was not returned for investigation.An internal investigation has been opened to address reports of a similar nature.(b)(4).
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