Catalog Number MP-17019-TKL |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/14/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device investigation report has not been submitted 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 would not flush after insertion and it was replaced.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 catheter with no relevant findings.The customer reported the catheter would not flush.The customer returned one epidural catheter, one snaplock adapter, and lidstock.The components were received connected together (reference 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 with no observed defects or anomalies.A manual flow test was performed using the returned components.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.A corrective action is not required at this time as there were no functional issues found with the returned sample.Other remarks: the reported complaint of the catheter not flushing 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 would not flush after insertion and it was replaced.The patient's condition was reported as fine.
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Search Alerts/Recalls
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