This report has been identified as b.Braun medical inc.(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the lot number, a batch record review could not be performed.No specific conclusions can be drawn.It was indicated in the event summary that multiple drug products were administered during the procedure.The reported kit catalog number contains the following drugs: 5 ml lidocaine 1% test dose 1.5 % lidocaine with epinephrine.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or involved drugs.All available information has been forwarded to the drug manufacturer.There is no current information available to suggest that the b.Braun product caused or contributed to the reported event.If additional pertinent information that impacts the result of the investigation becomes available, a follow-up report will be filed.
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As reported by the user facility: reports the patient had a neurotoxicity after the procedure.The patient started labor with twins.An epidural was performed with the catheter.Patient was converted to a c-section.After the procedure, the patient had numbness and weakness bilaterally in lower extremities and bladder incontinence.Patient had inability to walk at all for approximately 1 week.The patient is currently walking with a cane.All tests including mri and emg were negative for a biologic cause.The facility protocol is to skin prep with chlora-prep prior to all epidurals and spinals, and not use prep in tray.Drugs given to patient were lidocaine with epinephrine from tray, skin wheel with lidocaine, bupivacaine, morphine, and fentanyl.Per follow-up correspondence with the reporting facility, the patient had no prior medical history, no renal diagnosis.It was determined that there were no issues with the insertion.The patient was sitting during prep, epidural inserted mid-line, l3-l4 for original plan of vaginal delivery.The patient was given 8 ml push of 0.25% bupivacaine and 100 mcg fentanyl, infusion of premade bag of 0.06% bupivacaine with fentanyl was set at 15 ml over 2 hours.Patient was converted to c-section due to the fetus not being in correct position for vaginal delivery.Patient was then given lidocaine 2% with epinephrine, 15 ml zofran, fentanyl, and 2 mg morphine-intravenous.At an unknown time the patient experienced calf pain.Bilateral dopplers were done, results negative.The patients inability to walk has resolved.
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