25 samples were received by our quality team for evaluation.All 25 samples were inside the original unopened package with end cap locked in correct position with no defects noted and deemed conforming product (applicators and package); therefore, the incident could not be verified.Retain samples were inspected for lot # 1033869 and there were zero (0) non-conformance out of 47 conforming applicators.A device history record review found no non-conformances associated with this issue during production of this batch.Though the complaint could not be verified based on the samples received for this complaint, 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.H3 other text : see narrative below.
|