Catalog Number 0250070500 |
Device Problems
Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/10/2019 |
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 in sterile packaging.
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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: a foreign material was found inside the package the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be foreign material fell inside during packaging or manufacturing.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.Gtin: (b)(4).
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Search Alerts/Recalls
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