Catalog Number EC-05500 |
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 11/16/2017 |
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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Issue reported: the clinician could not push medications through the catheter.The device was replaced.The patient's condition was reported as fine.
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Manufacturer Narrative
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(b)(4), no lot number was provided.A device history record review was performed based upon a lot number from sales history data.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.No lot number was provided.A device history record review was performed based upon a lot number from sales history data.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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Issue reported: the clinician could not push medications through the catheter.The device was replaced.The patient's condition was reported as fine.
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Search Alerts/Recalls
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