The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4)has been listed in sections and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Investigation summary: bd received a sample from the customer facility for investigation.The sample was evaluated and the customer's indicated failure mode for the sleeve pierced by the needle with the incident lot was observed.Additionally, retention samples were selected from inventory for visual inspection and upon completion, the customer's indicated failure mode 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.Investigation conclusion: based on evaluation of the customer sample, the customer¿s indicated failure mode for side-pierced sleeve with the incident lot was observed.Evaluation of the retain samples was conducted and side pierced sleeves were not observed.Root cause description: based on the investigation, a root cause could not be determined.
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