Oem manufacturer: 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 and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: na.Investigation summary: retain samples of the two noted production batches were reviewed and found to conform to cap application and pull off forces.This indicates no concern during the manufacture of the container from a dimensional point of view.It is most probably (without further relevant information) that the cap/closure was not effectively applied by the line operator during the secondary application process causing it to "detach" as advised.The application process has been reviewed and found to be effective in its application.Random audit of the process and feedback has been sought for any concerns that may be identified that may require correction.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-conformance's during manufacturing of the product.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned, and retained samples were found to conform to specification.Root cause description: supplier (b)(4).Rationale: based on the investigation, no additional investigation and no capa is required at this time.
|