Investigation summary: no samples (or pictures) have been received for investigation.Dhr of lot 1711243 is reviewed, not finding any annotation or deviation regarding the alleged defect.Ten retained samples of lot 1711243 are evaluated.Upon visual inspection of these ten retained samples, no damage or molding defect can be observed in the tip or thread of any of them.Tip and thread verification is done with an iso594 compliant gauge pass/non pass (#(b)(4) respectively) to the first lot manufactured in the month per manufacturing line according to procedure (b)(4).Both verifications are done with these gauges and retained samples according to procedure (b)(4).All samples meet iso594 for both verifications.Final products in this manufacturing line, for this reference and lot size are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures ((b)(4)): 1.Visual inspection: molding: 2 injections per shift.Printing: 32 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Assembly: 32 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Primary packaging: 1 advance-step (without product) per hour, after any intervention in the equipment, and once at the beginning of the shift.Secondary packaging: 1 shelf-package per pallet.2.Functional inspection printing: once in the first pallet and once in last pallet of the lot.Assembly: once in the first pallet and once in last pallet of the lot.Primary packaging: once in the first pallet and once in last pallet of the lot.Investigation conclusion: not confirmed.Since no incident has been found during manufacturing process records related to this defect and according to results obtained from verification with retained samples, no manufacturing defect has been found that could cause the alleged defect and the root cause cannot be determined.
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