"multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0001275590.Medical device expiration date: 2020-09-30.Device manufacture date: 2018-12-03.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown".Investigation summary: failure mode could not be confirmed through sample analysis.All thirteen (13) trays were opened and each bupivacaine vail was visually inspected for obvious defect.No defects were observed.Liquid within each vial was clear and without any visible particulate matter.Investigation conclusion: a dhr review of all applicable manufacturing records for lot 0001275590 did not identify any issues that may have contributed to the reported failure mode.Root cause description: based on the complaint investigation, a probable root cause could not be identified for the reported failure mode.The investigation identified a previous capa (capa 67717) performed by the bd anesthesia quality group that specifically investigated the ¿ineffective anesthesia¿ failure mode.Refer to capa (b)(4) for additional information regarding the outcome of the investigation.Likewise, the investigation identified a summary for previously investigated complaints (pic: (b)(4)) which provides rationale and information regarding the potential ineffective anesthesia outcome during the use of an anesthesia product code.Based on a review of all of these sources, the current complaint investigation could not identify a definitive root cause nor could any potential contributor be identified for this specific complaint failure mode.Rationale: since no probable root cause was identified for this failure mode, the investigation was not able to identify any corrective actions for this complaint.Based on the reported failure mode, supplier quality notifications ((b)(4)) has been previously sent to the vendor (pfizer) to notify the vendor of the reported failure mode (ineffective anesthesia bupivacaine).Likewise, the complaint will be entered into the complaint management system and will be tracked & trended for future occurrences and reviewed/investigated through the quality data analysis (qda) process if an adverse trend is identified.
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