Model Number 405671 |
Device Problem
Product Quality Problem (1506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2022 |
Event Type
malfunction
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Event Description
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It was reported that the anesthesia in the bd¿ whitacre spinal tray was ineffective and didn't properly numb the injection site.The following information was provided by the initial reporter: "drugs within spinal tray did not properly numb the injection site.".
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Manufacturer Narrative
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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.
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Event Description
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It was reported that the anesthesia in the bd¿ whitacre spinal tray was ineffective and didn't properly numb the injection site.The following information was provided by the initial reporter: "drugs within spinal tray did not properly numb the injection site.".
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Manufacturer Narrative
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H6: investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.H3 other text : see h10.
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Search Alerts/Recalls
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