Model Number ARTHREX ACP DOUBLE SYRINGE SYSTEM |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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On (b)(6) 2021, it was reported by a distributor via sems that an abs-10010s double syringe leaked rpr from plunger during injection.This was discovered during prp therapy.Surgeon completed case successfully using another double syringe; patient was not affected.
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Search Alerts/Recalls
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