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Catalog Number 405699 |
Device Problem
Measurement System Incompatibility (2982)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Pma/510(k)#: enforcement discretion.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that the marcaine in the bd¿ spinal anesthesia tray was not working properly.This was discovered during use.The following information was provided by the initial reporter: material no.405699, batch no.0001270921.It was reported that there has been issues with the marcaine in the anesthesia trays not properly working as needed.Per email: the information provided was as follows: thursday in a caesarean section administer the marcaine that comes in the tray, following the stipulated process and patient can lift the legs and report sensation in the area.He opened another tray and repeated the process, without obtaining results.On sunday, another of the anesthesiologists reports the same and the same result with a patient.On monday, indicates the same thing happens to him, already aware of the event in the afternoon he uses the spinal bupivacaine that we have in the pharmacy (due to the shortage that there was of the trays with the marcaina).None of the patients has tolerance to the anesthesia reported.On monday afternoon the doctor indicated the patient responded as expected.At the moment, they are using the trays and not the medication in them.
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Manufacturer Narrative
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Investigation: photos were received for evaluation.Customer provided photographs were provided.Vial appears as intended with no obvious defects.Fluid appears to be clear.No avenue to evaluate drug potency without the physical sample.Failure mode could not be confirmed.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 (hospital / pfizer) will be notified of the reported failure mode from the customer.A device history record review of all applicable manufacturing records for lot 0001270921 did not identify any issues that may have contributed to the reported failure mode.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 67717 for additional information regarding the outcome of the investigation.
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Event Description
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It was reported that the marcaine in the bd¿ spinal anesthesia tray was not working properly.This was discovered during use.The following information was provided by the initial reporter: material no.405699 batch no.0001270921 it was reported that there has been issues with the marcaine in the anesthesia trays not properly working as needed.Per email: the information provided was as follows: 1.Thursday in a caesarean section administer the marcaine that comes in the tray, following the stipulated process and patient can lift the legs and report sensation in the area.He opened another tray and repeated the process, without obtaining results.2.On sunday, another of the anesthesiologists reports the same and the same result with a patient.3.On monday, indicates the same thing happens to him, already aware of the event in the afternoon he uses the spinal bupivacaine that we have in the pharmacy ( due to the shortage that there was of the trays with the marcaina).None of the patients has tolerance to the anesthesia reported.On monday afternoon the doctor indicated the patient responded as expected.At the moment, they are using the trays and not the medication in them.
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Search Alerts/Recalls
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