Catalog Number 0250070500 |
Device Problems
Contamination (1120); Packaging Problem (3007)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/29/2022 |
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 the foreign material was found inside the sterile package.
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Event Description
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It was reported the foreign material was found inside the sterile package.
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Manufacturer Narrative
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The device manufacturer date is not known.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: foreign substance in packaging.Probable root cause: manufacturing/assembly/ service error.Incorrect or inadequate packaging.Severe shipping conditions.User error.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
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Search Alerts/Recalls
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