Model Number ACP KIT SERIES I |
Device Problems
Leak/Splash (1354); Loose or Intermittent Connection (1371); Device Slipped (1584)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/13/2021 |
Event Type
malfunction
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Event Description
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On (b)(6) 2021, it was reported by a sales representative via sems that an abs-10012 acp kit inner syringe fell out of the syringe during the blood draw.This was discovered during a procedure.Additional information received 10/19/2021.Blood leaked from syringe when the inner syringe fell out.Case was completed with a new kit because afterwards syringe was too loose and would not go back in.
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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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Search Alerts/Recalls
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