Date of event: unknown.(b)(6).Investigation results: summary: a sample was received for evaluation.It has no packaging flow wrap.It has the tip cap, plunger rod-rubber stopper and saline solution.The barrel label confirms the lot#: 7264801.The saline solution is up to the 3ml mark and this is a 5ml syringe therefore failure mode is verified.It is possible that the product with low fill volume may have made it through to packaging.Since this is a limited issue, no further actions will be taken.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 a device history review was completed and it was noted that there is documentation for low fill volume being found twice during the plunger rod quality check on (b)(6) 2017.An acceptable quality limit of 0.25% was performed each time and both checks passed.Conclusion: investigation comments: all our inspections performed while manufacturing this batch were accepted; there were two instances where low fill volume was detected; stat sampling was performed and passed.Update may 1, 2018: a sample was received.It has no packaging flow wrap, it has the tip cap, plunger rod-rubber stopper and saline solution.The barrel label confirms the lot#: 7264801.The saline solution is up to the 3ml mark; this is a 5ml syringe.Product within specification? yes? no? root cause: possible root cause could be product with low fill volume may have made it through to packaging.Update may 1, 2018: possible root cause.An escape when the low fill volume was detected in the process inspections.
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