Material#: 405637 batch#: 0001519886 it was reported by customer that the drug bupivacaine was not working on the patient from the bd spinal tray material# 405637 (possibly) lot# 0001519886 verbatim: the drug bupivacaine was not working on the patient from the bd spinal tray material# 405637 (possibly) lot# 0001519886 additional information received 25jan2024: the patient required general anesthesia for the procedure.2.The patient required general anesthesia, which also delayed the procedure by about 5 minutes.3.A photo of the lot number was provided.The vial was discarded after use.4.There was no known clinical adverse outcome.5.General anesthesia 6.Stable, discharged home and recovering from procedure.
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No samples or photos received for investigation.A device history review was performed for lot 1519886, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Retained samples from the same lot were evaluated, no issues or defects observed.The sterilization release record was reviewed for the finished good trays, the requirements for it's release were met.Based on the investigation results, no manufacturing related defects could be identified and therefore, a cause for the reported incident could not be determined.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Manufacturing personnel have been notified of this incident to increase awareness.
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