Unknown manufacturer: 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 and the (b)(4) fda registration number has been used for the manufacture report number.Device expiration date: unknown.Initial reporter facility name: (b)(6).Device manufacture date: unknown.(b)(4).Investigation summary: no product or photo was returned by the customer.The customer complaint of the device under infusing could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model and lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: due to no sample being received, an investigation could not be performed and a root cause could not be determined.
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It was reported that the unspecified bd intravascular administration set experienced underinfusion.The following information was provided by the initial reporter: material no: unknown, batch no: unknown.We had a recent error on (b)(6) 2020 when 400 mg iron sucrose/250 ml ns ivpb was being administered.The infusion was started at 2201.When the nurse went to check the infusion ~4.5 hours later, she found that the iv bag still had ~100 ml of fluid in it even though the pump volume record showed that 279 ml was infused.
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