Catalog Number 3910-500-312 |
Device Problems
Contamination (1120); Contamination /Decontamination Problem (2895)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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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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The product was returned for investigation and the reported failure mode was not confirmed.Alleged failure: foreign matter was mixed in the sterilization bag, so the use was postponed without opening.I want you to confirm what is going on.The root cause is a manufacturing issue.The failure mode will be monitored for future reoccurrence.
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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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