Catalog Number NLD-15545C-21 |
Device Problem
Missing Value Reason (3192)
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Patient Problem
Awareness during Anaesthesia (1707)
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Event Date 02/12/2016 |
Event Type
Injury
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Manufacturer Narrative
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Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
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Event Description
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The user facility reported that a patient was given a spinal injection, and the drug (bupivacaine) did not form a block.General anesthesia was provided as a result.No permanent injury was reported.
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Manufacturer Narrative
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The actual sample was not returned for investigation.The supplier of the anaesthesia medication completed a review of manufacturing records for the reported lot and concluded that the product met with specifications at final testing.The supplier also tested retained samples from the same lot for potency.All testing found the product to meet with specifications.
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Search Alerts/Recalls
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