E.5.Initial reporter phone #: (b)(6).H.6.Investigation summary: bd had not received samples, but 5 photos were provided for investigation.The photos were reviewed and the indicated failure mode for torn label was observed in one of the photos.Retention samples were not available for inspection.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode, torn label.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
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