Catalog Number 401385 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Awareness during Anaesthesia (1707)
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Event Date 11/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(6) has been listed and the (b)(6) fda registration number has been used for the manufacture report number.The reported lot # [960803a] was not found for the reported catalog # [401385].Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
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Event Description
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It was reported that the anesthesia in 2 anesthesia tray procedure spinal kits was ineffective during use.The following information was provided by the initial reporter: "2 failed spinal in the row ( cerclage and section) due to bupi vial from the kit".
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Event Description
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It was reported that the anesthesia in 2 anesthesia tray procedure spinal kits was ineffective during use.The following information was provided by the initial reporter: "2 failed spinal in the row ( cerclage and section) due to bupi vial from the kit".
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Manufacturer Narrative
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H6: investigation summary there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and but no records of lot 960803a were found for the reported device.Therefore, a review could not determine if there were any manufacturing related issues found during production.H3 other text : see h10.
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Search Alerts/Recalls
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