Initial reporter last name: (b)(6).Initial reporter phone#: (b)(6).Initial reporter fax#: (b)(6).Investigation summary: the analysis of samples sent by the customer (3 samples) was carried out.Through the analysis, it was possible to observe the incident of difficulty in moving the plunger.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.All samples had silicone inside the syringe, but it was poorly spread, which caused difficulty in moving the plunger.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 possible cause of the incident is a failure of the siliconizing nozzle.
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