Root cause: the debris has been identified as coming from two potential sources prior to and during the manufacturing process.These sources are vendor supplied products and during the manufacturing process.A review of the representative samples has identified the potential source of contamination as a stop sharp blank box (raw material (b)(4)).Corrective action: an engineering change order (b)(4) was implemented january 24, 2017, to add a glassine bag for the forceps and needle holder instruments in the finished good tray.Also, there will be a visual inspection on the sub-assembly prior to placing the components in the tray.Investigation summary an internal complaint (b)(4) was received indicating there was debris inside a sterile finished good pack (part number 89-8672).A representative sample was returned for evaluation.This revealed there was a black speck on the foam block inside of the tray and a hair on the outside of a ziplock bag that these sample items were in for evaluation.Deroyal does not place this ziplock bag into the tray.The initial review has indicated potential sources of the black debris as the following: the forceps or needle holder which are placed into the 16-ounce bowl or the stop sharp blank box that is placed into the tray.Since january 24, 2017, the forceps and needle holder are packaged in a glassine bag prior to placement in the 16-ounce bowl.The work order was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.This work order was built on december 1, 2016, prior to implementation of an eco to place the instruments into a glassine bag.Due to the complaint investigator identifying the stop sharp blank box as a potential source of contamination, a supplier corrective action request has been issued to aspen surgical products, which supplies the component.As of the date of this report, a response has not been received.Preventive action: due to the investigation and root cause determination, a preventive action has not been taken.
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