There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed in manufacturer name, city and state and mfr site and the (b)(4) fda registration number has been used for the manufacture report number.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no samples were received for investigation of complaint reference (b)(4) reported via post market survey; however, the customer reported that a 'back flow of fluid leading to an under infusion' and 'obstruction' was detected during use with a bd back check valve product.No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance a lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the bd back check valve products in the past 12 months.
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