Catalog Number 0620030301 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/09/2023 |
Event Type
malfunction
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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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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: noticed hair after opening the package.Probable root cause: 1.Assembly error.2.Damage during shipment (inadequate packaging).3.Damage during shipment (abuse during transit).4.Use error.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text : 81.
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Search Alerts/Recalls
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