Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.No lot # provided.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Investigation summary: photo/ sample revealed 2 white dots on face of syringe no sign of moisture just a slight ring.Product within specification? yes.No.2 white dots are bubbles.Moisture is silicone.Investigation conclusion: root cause for 2 white dots- these white dots are bubbles that come from molding vents on mold partially plugged with plastic gas discharge preventing/obstructing primary vent discharge or mold melt disk probes partially obstructed which creates a jetting effect in the plastic flow.In turn, this creates head and uneven flow through the gates and causes bubbles.Moisture in syringe: 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, however, some silicone may not be perfectly distributed.Silicone has been in use in this application for over 20 years, with estimated distribution well in excess of 25 billion units.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.
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