The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 17-feb-2023.H6: investigation summary one hundred ninety-seven sealed packaged in an opened carton box were provided to our quality team for investigation.Through visual inspection, it was observed that cartons outside label mismatched the product inside the box.The carton box label stated 5ml ll, material number 309646, batch number 2221570, and a quantity of 125.However, the products inside the box were 197 sealed packaged 3ml ll with material number 309657 and batch number 2215946 printed on their top web packages.Potential root cause for the incorrectly labeled box defect is associated with a failure to follow the packaging material handling processes.This defect most likely occurs due to an inadequate line clearance after production of the 3ml batch likely led to the box being left unattended in a location where a palletizing operator may have mistakenly placed it on the 5ml line utilizing the same box.As a corrective action, re-education of all palletizing operators and team members associated with the packaging of the 3ml and 5ml lots to applicable procedures for line clearance and disposing of product properly to prevent mixes will be performed.A device history record review was completed for provided lot number 2221570.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
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