Correction new lot #: lot # provided: 1711216.Medical device expiration date: 2022-10-31.Device manufacture date: 2017-11-07.Investigation results: one 20 ml ll sample, lot number 1711216 and one picture was received by our quality team for investigation.Upon visual inspection of this sample, no damage or molding defect can be observed in the sample received that could verify the alleged defect.A device history record review found no non-conformances associated with this issue during production of this batch and the results of silicone weight, break out and sustaining force tests performed during manufacturing process of lot 1711216 were within specification limits.Silicone weight, break out and sustaining force tests was performed and the sample with results within specification limits.Final products in this manufacturing line, for this reference and lot size are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based upon the quality team's investigation, the root cause of this incident cannot be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.According to results obtained during manufacturing process and sample received, no manufacturing defect has been found in the syringes that could have caused the alleged defect.Based on severity and occurrence no formal capa is required according to internal procedure.
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