E1: initial reporter address: (b)(6).H.6 investigation summary: bd had not received samples, but 4 photos were provided for investigation.The photos were reviewed and the indicated failure mode for missing tube labels was observed.Additionally, retention samples from bd inventory were visually inspected and no label defects were found.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, missing 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.
|