Catalog Number EC-05500 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/21/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device is unavailable for investigation.The manufacturer will continue to monitor and trend related events.
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Event Description
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The anesthesiologist inserted the epidural catheter and tried to inject medication then a bubble of liquid came out around 1-2 cm from snaplock.New epidural catheter was inserted.The patient's condition was reported as fine.
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Manufacturer Narrative
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(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 a potential root cause 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 leaking could not be determined based upon the information provided and without a sample.
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Event Description
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The anesthesiologist inserted the epidural catheter and tried to inject medication then a bubble of liquid came out around 1-2 cm from snaplock.New epidural catheter was inserted.The patient's condition was reported as fine.
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Search Alerts/Recalls
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