Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: it was reported by the consumer they were unable to push past 3ml.As a sample was unavailable for return, a thorough sample investigation could not be completed.It could be possible the customer had some product on the higher end of specification inducing more force than normal required to expel the solution.A device history record review was completed for provided material number 306546, lot number 1035833.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Previous investigations have revealed that improper silicone application within the syringe barrel can create plunger resistance.Several quality initiatives have been implemented on our manufacturing line to ensure that the silicone application is properly applied during the manufacturing process.Additionally, a monitoring program is also in place to verify the silicone is uniformly applied to the syringe barrel.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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