(b)(6).Investigation summary: a photo and a sample was received for evaluation.The sample revealed a hair inside the syringe therefore failure mode is verified.Operator interaction with the product is minimal, however, hair contamination is possible if proper gowning is not followed.All operators are trained to a gowning procedure to minimize risk of hair contamination.Per procedure, hairnets/beard covers must always be put on before the smock.The hairnet and beard cover must cover all hair.Hairnets and beard covers must be discarded once removed.No corrective actions are required at this time as the defect rate is within allowed quality limits per bd¿s specifications.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.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: no related defects or qns were recorded in the dhr.Rationale: n/a, defect rate within allowed limits.
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