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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 04/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
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Event Description
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It was reported that the package had a 1.5cc vial instead of the 3cc vial.The product was difficult to mix because of the ration of liquid to bbtcp.The surgeon was able to inject at the site with no patient complications reported.There was no backup kit available.No impact to patient, just less product used than planned.No delay.
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Search Alerts/Recalls
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