Device expiration date: unknown.Device manufacture date: unknown.Pma / 510(k)#: enforcement discretion.Investigation summary: thirteen samples were provided for evaluation.The investigation was not able to identify or confirm any contribution for the manufacturing plant to the reported failure mode.Specific to the handling of the drugs, the investigation noted specific procedures to control the handling of any raw material drug component during the receipt, storage, and use in the manufacturing process.A review of the temperature monitoring system within the (b)(4) facility did not identify any excursions that would have negatively affected any of the raw material drug components used within this product code.The investigation did identify this failure mode as a previously known issue.Over a period of more than 10 years, no test result from samples returned due to ineffective anesthesia has ever failed to meet specifications.The causes of ineffective anesthesia have been well documented in clinical literature for many years.Whereas a strong history of testing has supported that drug potency is not the cause, the actual cause may not always be ascertained.Bd has a long history of test results to support that drug potency issues have not been the cause of ineffective anesthesia events reported to bd through the complaint system.As a preventive action, the vendor of the applicable drug component, will be notified of the reported failure mode from the customer.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.Although a lot number was not provided for this particular complaint it is suspected that the lot number may be identical to complaint (b)(4), mfr# 1625685-2019-00032, (lot # 0001275590) since both complaints were reported at the same time by the same customer.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.Dhr review for this lot is captured under complaint (b)(4).Investigation conclusion: the investigation was not able to identify or confirm any contribution for the manufacturing plant 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; 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.
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