H.6.Investigation: customer provided photographs were provided.The photograph returned does not include the sample.Sample could not be visually evaluated as a result.Failure mode could not be confirmed.The investigation was not able to identify or confirm any contribution to the reported failure mode from the factors noted above.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 mannford facility did not identify any excursions that would have negatively affected any of the raw material drug components used within this product code.Based on the complaint investigation, a probable root cause could not be identified for the reported failure mode.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 (hospira / pfizer) will be notified of the reported failure mode from the customer.A device history record review of all applicable manufacturing records for lot 0001272749 did not identify any issues that may have contributed to the reported failure mode.H3 other text : see h.10.
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