Catalog Number JC-05400-B |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.
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Event Description
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The catheter was blocked and there was no flow.A new catheter was inserted.The patient's condition was reported as fine.
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Manufacturer Narrative
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Qn#(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.A corrective action is not required at this time as the potential cause of the catheter being blocked could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the catheter being blocked could not be determined based upon the information provided and without a sample.
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Event Description
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The catheter was blocked and there was no flow.A new catheter was inserted.The patient's condition was reported as fine.
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Search Alerts/Recalls
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