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Model Number K30003010 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The reported event could be confirmed, since inspection of other lots on the shelf were found with the same issue.Based on investigation, the root cause was attributed to a co-mingling related issue.The failure was caused by two partial vial lot boxes (1.5ml and 3.0ml) were consolidated into one box.A non-conformance was opened in the legacy wright nce system and a field action assessment was performed.Packaging discarded.
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Event Description
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It was reported that the kit had 1.5cc rhpdgf vial instead of the 3cc rhpdgf vial.The kit was mixed and combined with a second unit of 1.5cc to get the 3cc total.This was combined with an additional 3cc kit as the surgeon wanted 6cc in total.
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Search Alerts/Recalls
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