Catalog Number JC-05400-B |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Information (3190)
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Event Date 12/21/2016 |
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.The manufacturer will continue to monitor and trend related events.
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Event Description
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The catheter was successfully inserted for a parturient woman.Then the physician experienced an abnormal resistance during injection of the anesthetic, leading to the need of inserting a new catheter.The patient's condition was reported as unknown.
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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.The customer reported the catheter was not injecting medication.The customer returned one epidural catheter, one snaplock adapter, and one 5ml syringe.The catheter and snaplock adapter were received connected together (reference attached files (b)(4)).The returned components were visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears typical but used.Adhesive material can be seen on the outer extrusion of the catheter.No other defects or anomalies were observed.A manual flow test was performed using the returned catheter and snaplock adapter.A 20ml lab inventory syringe was connected to the returned snaplock adapter and catheter.Using hand pressure, the water was injected.Water could be seen immediately exiting the distal end of the catheter.No blockages were found.Other remarks: a corrective action is not required at this time as there were no functional issues found with the returned sample.The reported complaint of the catheter not injecting medication could not be confirmed based on the sample received.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The returned components passed a functional flow test.There were no functional issues found with the returned sample.
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Event Description
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The catheter was successfully inserted for a parturient woman.Then the physician experienced an abnormal resistance during injection of the anesthetic, leading to the need of inserting a new catheter.The patient's condition was reported as unknown.
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Search Alerts/Recalls
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