Catalog Number 0250070520 |
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 10/19/2020 |
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 manufacture 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 sterile packaging.
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Manufacturer Narrative
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Alleged failure: fuzz type material found inside (operating room sterile field) reported to vendor representative.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be the tyvek cover was dirty or the packagers hand had contaminants during packaging.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 sterile packaging.
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Search Alerts/Recalls
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