Catalog Number JC-05400-DCS |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/06/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The facility has communicated that the device is not available for evaluation.The manufacturer will continue to monitor and trend related events.
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Event Description
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The epidural anesthesia was not working well, so medical staff inserted two catheters.When the catheters were removed they seemed to be blocked or kinked.The consequence was to process a general anesthetic.
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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 catheter with no evidence to suggest a manufacturing related cause.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 epidural anesthesia was not working well, so medical staff inserted two catheters.When the catheters were removed they seemed to be blocked or kinked.The consequence was to process a general anesthetic.
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Search Alerts/Recalls
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