Investigation results: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for tubing leakage with the incident lot was observed.Visual inspection of the contaminated sample was performed and a cut in the tubing was observed.Submerged leak testing was conducted on the unused sample, and no cuts or leakage were identified.Additionally, retention samples were selected from bd inventory for submerged leak testing and upon completion, the customer's indicated failure mode for leakage was not observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd has initiated further investigation relating to this issue through a capa.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.Based on evaluation of the customer samples, the customer¿s indicated failure mode for tubing leakage with the incident lot was observed.Further investigation has been initiated through a capa.The investigation is still on-going and improvements will be made as the potential causes are identified.A capa has been initiated to document further investigation and root cause analysis relating to this issue.The investigation is currently on-going and will be updated as the potential root cause(s) are identified.Based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this issue and implement corrective actions.The investigation is currently on-going and further improvements will be made as the potential root cause(s) are identified.
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