Investigation summary: bd had not received samples or photos for investigation.Therefore, 48 retention samples from bd inventory were evaluated by visual examination, and 12 by functional testing, and no issues were observed relating to overflow / overfill as all samples met specifications.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 overflow / overfill.Bd was not able to identify a root cause for the indicated failure mode.
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