Initial reporter zip:(b)(6).Investigation summary: no sample or photo was available for review.Based on the description, it is possible the observed substance is silicone residue.It would be helpful to evaluate samples to confirm the reported defect.Silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.The silicone application process is designed to provide an even distribution of silicone on the interior of the syringe barrel.Silicone has been in use in this application for over 20 years.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.Silicone is applied as a spray of particles to the inside of the barrel.It is unclear what type of storage and handling conditions the product was subjected to after leaving the manufacturing plant.It is possible certain conditions outside manufacturing environment contributed to the attachment of silicone to the barrel walls as reported by customer.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.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.
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