Investigation summary: bd had not received samples, but two (2) photos were provided for investigation.The photos were reviewed and the indicated failure mode for damaged hemogard cap was observed.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and the issue of damaged hemogard cap was not observed.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 of damaged hemogard cap.Bd was not able to identify a root cause for the indicated failure mode.
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