Catalog Number SJ-05501 |
Device Problems
Bent (1059); Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/17/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device is reportedly unavailable for investigation.The manufacturer will continue to monitor and trend related events.
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Event Description
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The tip of the epidural needle bent during placement and prevented the epidural catheter from threading.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 needle with no relevant findings.A corrective action is not required at this time as the potential cause of the lor syringe leaking 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 needle with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the needle tip bending during use could not be determined based upon the information provided and without a sample.
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Event Description
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The tip of the epidural needle bent during placement and prevented the epidural catheter from threading.The patient's condition was reported as fine.
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Search Alerts/Recalls
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