(b)(6).Investigation results: summary: 12 photos were received for evaluation by one of our quality engineers.Case box label, shelf box label and barrel label confirm the lot# 7291824.The photos show the packaging flow wrap damaged/torn towards the end where the plunger rod thumb press is therefore failure mode is verified.While root cause could not be definitively determined, it is possible that the packaging was exposed to excessive compression force during handling or transportation inducing damages to the shelf box and packaging flow wrap.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 indicated that there was no documentation of issues for the complaint of batch 7291824 during this production run.Conclusion: investigation comments: all our inspections and testing performed while manufacturing this batch were accepted.No rejections were documented.On (b)(6) 2018.Twelve (12) photos were received.Case box label and shelf box label and barrel label confirm the lot# 7291824.The photos show the packaging flow wrap damaged/torn towards the end where the plunger rod thumb press is.Product within specification? ¿ yes ¿ no root cause: root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections and testing were accepted during the production of this batch.Possible root cause.Handling/ transportation.Possible the packaging was exposed to excessive compression force inducing damages to the shelf box and packaging flow wrap.
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