H.6 investigation summary: bd had not received samples or photos for investigation.Therefore, ten (10) retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to tube push off as all samples met specifications.Additionally, one hundred (100) retention samples were visually examined, and no issues were identified.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 is unable to be confirmed for the indicated failure mode of tube push off.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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