Investigation summary: two (2) samples were received for evaluation.The tip cap of each sample has black discoloration, therefore failure mode is verified.After opening the packaging flow wrap the tip caps were inspected finding embedded black discoloration.This tip cap discoloration was induced during the molding process of the tip caps.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: this is the first complaint for the lot# 8242589 for the same defect or symptom.There was no documentation of issues for the complaint of batch 8242589 during this production run.Root cause description: this tip cap discoloration was induced during the molding process of the tip caps.
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