Model Number 405671 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/11/2019 |
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.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
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Event Description
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Material no: 405671, batch no: 0001302639.It was reported that during use of the tray spn whit25g3.5 l/b-d/e plast drape the trays have bad bupivacaine in them.This occurred on 25 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: we have about 25 spinal trays that we believe have bad bupivacaine in them.
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Event Description
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Material no: 405671, batch no: 0001302639.It was reported that during use of the tray spn whit25g3.5 l/b-d/e plast drape the trays have bad bupivacaine in them.This occurred on 25 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: we have about 25 spinal trays that we believe have bad bupivacaine in them.
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Manufacturer Narrative
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Investigation summary: no samples were received for evaluation.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 (b)(6) facility did not identify any excursions that would have negatively affected any of the raw material drug components used within this product code.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.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.A device history record review of all applicable manufacturing records for lot 0001302639 did not identify any issues that may have contributed to the reported failure mode.
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Event Description
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Material no: 405671, batch no: 0001302639.It was reported that during use of the tray spn whit25g3.5 l/b-d/e plast drape the trays have bad bupivacaine in them.This occurred on 25 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: we have about 25 spinal trays that we believe have bad bupivacaine in them.
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Manufacturer Narrative
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H6.Investigation: no samples were received for evaluation.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.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.A device history record review of all applicable manufacturing records for lot 0001302639 did not identify any issues that may have contributed to the reported failure mode.H3 other text : see h10.
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Search Alerts/Recalls
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