Investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for leakage within the holder (sleeve leakage) with the incident lot was observed.Additionally, it was noted that the rubber sleeve component was missing.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.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for leakage within the holder and missing rubber sleeve with the incident lot was observed.Root cause description: based on the investigation, the most likely root cause was determined to be related to a manufacturing issue.
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