Model Number 406704 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.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 4 bd¿ spinal anesthesia trays had holes in their sterile packaging, compromising their sterility.The following information was provided by the initial reporter: "it was reported that there are holes in the sterile covering." "we are experiencing another problem with the spinal tray.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/1/2021.H.6.Investigation: five photos and one physical sample of lot 0001419161 were provided to our quality team for investigation.Through visual inspection, no interior broken components were identified but damage to the interior of the cover packaging was observed, therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001419161 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.H3 other text : see h.10.
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Event Description
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It was reported that 4 bd¿ spinal anesthesia trays had holes in their sterile packaging, compromising their sterility.The following information was provided by the initial reporter: "it was reported that there are holes in the sterile covering."."we are experiencing another problem with the spinal tray".
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Search Alerts/Recalls
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