Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: it was reported there was a syringe scale error.To aid in the investigation, one sample in a sealed packaging blister and one photo were received for evaluation by our quality team.A visual inspection was performed and the scale marking is skewed.No other defects or imperfections were observed.The photo provided shows the sample received.It could be possible that the printing pad had a jam inducing the scale marking issue.A device history record review was completed for provided material number 302832, lot number 1026884.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the printing process was performed.Settings and adjustments were found acceptable.The flow of products was good.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.Our quality team regularly reviews the collected data for identification of emerging trends.
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