Catalog Number JC-05400-B |
Device Problems
Difficult to Remove (1528); Retraction Problem (1536)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.
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Event Description
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It was reported that during an accidental removal of the catheter while removing it through the needle, the catheter scratched in the needle.The catheter slips incorrectly in the needle.It happened three times.The staff had to insert the epidural needle with a new kit.The patient's condition was reported as good.
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Manufacturer Narrative
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(b)(4).A device history record review was performed on the epidural catheter and needle 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 and needle with no relevant findings.The potential cause of issues with the catheter and needle could not be determined based upon the information provided and without a sample.
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Event Description
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It was reported that during an accidental removal of the catheter while removing it through the needle, the catheter scratched in the needle.The catheter slips incorrectly in the needle.It happened three times.The staff had to insert the epidural needle with a new kit.The patient's condition was reported as good.
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Search Alerts/Recalls
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