Catalog Number 0620030301 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that there was foreign material inside the sterile packaging.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: not sterile.Probable root cause: 1.System design (tolerance stack up issue) 2.Manufacturing / assembly/ service error.3.Use error.4.Damage during shipping (inadequate packaging).5.Damage during shipping (abuse during transit).6.Gas connector cross threading.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
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Event Description
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It was reported that there was foreign material inside the sterile packaging.
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Search Alerts/Recalls
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