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.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Investigation conclusion: part number and lot number is unknown; a lot history review could not be performed.Root cause description: no root cause can be determined as no samples were received.Rationale: capa is not required at this time.
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It was reported that the bupivacaine anesthesia in the unspecified bd¿ spinal tray was ineffective and the patient had to be treated with general anesthesia.The following information was provided by the initial reporter: "aspiration".Reported incident date? several dates since (b)(6) 2020 until last month.Please confirm which item in the spinal tray malfunctioned the spinal bupivacaine part/ref/item number? do not have it.Lot number? unable to get that, but they are some of the boxes sent in the last months qty of damaged product involved? i would say 4-5 instances where no block was obtained after a very uneventful spinal technique.How many times has this issue occurred? 4-5 times.Please confirm patient not harmed.No harm, but all required to convert to general anesthesia, no time to repeat spinal".
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