The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 9/23/2021.H.6.Investigation: it was reported that there is a box where the sterility of the packages have been compromised.To aid in the investigation, two shelf boxes, each with forty-eight units, for a total of ninety-six units in packaging blisters were received for evaluation by our quality team.A visual inspection was performed.The packaging blisters are in sets of four and each set has one packaging blister with an open seal.The open packaging blister is at one of the sides in each set.No other defects or imperfections were observed.This defect could be possible during the packaging process if, during the slitting operation, a process variation occurred inducing the packaging web being cut short.A device history record review was completed for provided material number 302830, lot number 1180467.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.The packaging process was reviewed.The settings and adjustments were correct.The slitting process was working correctly.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
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