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 08/13/2021 |
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 a breach in the sterile barrier.
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Event Description
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It was reported that there was a breach in the sterile barrier.
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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: hole in packaging.Probable root cause: incorrect or inadequate packaging, severe shipping conditions, improper storage.
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Search Alerts/Recalls
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