Model Number ARTHREX ACP DOUBLE SYRINGE SYSTEM |
Device Problems
Mechanical Problem (1384); Material Separation (1562); Incomplete or Inadequate Connection (4037)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/29/2021 |
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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It was reported that the abs-10010s syringe fell apart right after the spin cycle and the blood fell on the floor.It appeared that the inner string would not screw in properly and would not tighten.The product was thrown away and a new kit was opened.
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Search Alerts/Recalls
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