Model Number CAT02438 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/25/2023 |
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 in the sterile packaging.
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Manufacturer Narrative
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Alleged failure: saw a hair inside sterile packaging before opening for a case.The failure(s) identified in the investigation is consistent with the complaint record.The root cause is a manufacturing issue.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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Event Description
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It was reported that there was foreign material in the sterile packaging.
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Search Alerts/Recalls
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