H.6.Investigation summary: two photos, one loose tip cap and one fully sealed 50-count tray confirmed to be from batch 9078938 (p/n 305822) were received and evaluated.It was observed in the photos, the loose tip cap and four of the tip caps in the unopened tray there was black embedded foreign matter particles present in the bottom and/or walls.It appeared to be burnt plastic with all the defective samples containing at least one particle larger than level 3 in size, which was rejectable per product specification.During production of the reported batch, an issue was identified and additional measures were taken to assure release of the product.Potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded fm is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.Per procedure, after start up, all molded parts are scrapped until no degraded plastic is observed.If this is not performed thoroughly a piece with this condition can get through.This type of defect is cosmetic and does not pose risk to the customer.No corrective actions are necessary based on the defective rate identified.Batch 9078938 is considered in compliance with our product specification requirements.
|