Investigation summary - to aid in the investigation, six photos were provided for evaluation by our quality team.Two photos show a packaging blister top web.The other photos show the top part of a vial, the vial and a syringe with a needle assembly connected to it.No other information could be obtained from the photos.A device history record review was completed for provided material number 305181, lot number 2228065.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed, and without the physical sample analysis a probable root cause could not be offered.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.
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