Three samples were received by our quality team for evaluation.With the sample provided, bd was able to verify the failure mode as the end cap was detached from the applicator body.A device history record was reviewed, and no non-conformances was noted during the manufacturing of this lot.The root cause is attributed to the equipment station for the end cap placement unto the applicator body.Corrective actions were initiated which led to bd conducting a voluntary recall on certain lots of the chloraprep hi- lite orange 26 ml applicator.Bd has verified that some of the product, which included this lot, had an applicator end cap that was improperly secured during the manufacturing process which resulted in broken glass dropping out of the applicator.
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