(b)(4).Investigation summary: one sample was received for evaluation, and it came in a sealed packaging blister.A visual inspection was performed.It has embedded degraded resin in the barrel flange area and with the top part of the barrel.The sample was scraped by using a knife, confirming the embedded resin.The embedded degraded resin can occur at the startup of an injection mold/press or intermittently during the injection molding process.Degraded resin inherently builds up in the barrel and hot-runner system of the tooling mold and press.The degraded resin can break loose and be molded into components.Inspections at the molding and assembly processes have special attention to this defect.During the accountability meeting, the production coordinator addressed the complaints.The complaint history for catalog# 309653 was done from 2018 to june 2020 with this customer.This is the 2nd complaint for any defect, the 1st complaint was reported in sept 2018.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: the embedded degraded resin can occur at the startup of an injection mold/press or intermittently during the injection molding process.Degraded resin inherently builds up in the barrel and hot-runner system of the tooling mold and press.The degraded resin can break loose and be molded into components.Rationale: capa not required at this time.
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