The customer did not retain the product lot information for this custom pak, therefore the device history records traceable to the reported procedure pack could not be reviewed.The customer reported that a piece of foreign was present in their pak.One plastic case with reported foreign material was returned.Several foreign materials were observed in the returned case, however, the customer identified that no.1 of attached picture is the foreign material of the reported complaint.Approximately 1 mm of brownish fiber-like foreign material was observed.Analysis from the particle lab determined that the material inside of the cup was wypall fibers (paper).While the sample confirmed the presence of wypall fibers, the root cause of the customer's complaint could not be conclusively determine as it is unknown when or where the material was first introduced to the pak.An action plan is in place to improve debris containment in the custom pak manufacturing environment to prevent recurrence.Complaints are continuously monitored to identify product and/or process areas where debris and hair is occurring.In addition, routine training and awareness is conducted with all manufacturing associates to reinforce the importance of wearing proper personal protective equipment (ppe) and maintaining clean work areas.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending.The manufacturer internal reference number is: (b)(4).
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