Model Number 405699 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/02/2021 |
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.Initial reporter email: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the bd whitacre¿ spinal tray experienced ineffective anesthesia that failed to work.The following information was provided by the initial reporter: the anesthesia doesn't function in the patient.
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Manufacturer Narrative
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H6: investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001424293 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the available information we are not able to identify a root cause at this time.
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Event Description
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It was reported that the bd whitcare¿ spinal tray experienced ineffective anesthesia that failed to work.The following information was provided by the initial reporter: the anesthesia doesn't function in the patient.
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Search Alerts/Recalls
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