The facility did provide photos/samples to aid in our quality engineer¿s investigation.With the sample, provided, bd was able to confirm 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 confirmed 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.Bd recognizes that customers place their trust in our products, and we strive to exceed the expectations of every customer.Your feedback is essential to our mission to improve the productivity and safety of health care globally.
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