Catalog Number ASK-05500-NRON |
Device Problem
No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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When the user did a test dose with a 2.5cc syringe, he/she was able to inject although there was some resistance.However, after that, when he/she attempted to inject 0.375% anapeine using a 20cc syringe, he/she was unable to inject it.Therefore, the catheter was replaced with a new kit.
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Manufacturer Narrative
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Qn# (b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter was unable to inject medication.The customer returned one snaplock assembly nrfit, one epidural catheter, and lidstock.The returned components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used.Biological material can be seen between the inner coils and adhesive can be seen on the outer extrusion.No other defects or anomalies were observed.A functional flow test was performed on the returned sample per amrq-000017 section 7.8; rev.9.The returned epidural catheter was inserted from the proximal end into the returned snaplock assembly until it bottomed out and the snaplock assembly was closed.The components were confirmed to be secured by tugging gently.The snaplock assembly was connected to the lab leak tester (ref (b)(4)) and the pressure was increased to 10 psi to establish flow.Water could be seen immediately exiting the distal end of the catheter.The flow rate was measured at 8.4ml/min (stopwatch: ref (b)(4)), which is within the specification of 1ml/min minimum.No blockages were found.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 and met flow rate specifications.There were no functional issues found with the returned sample.No further action is required at this time.
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Event Description
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When the user did a test dose with a 2.5cc syringe, he/she was able to inject although there was some resistance.However, after that, when he/she attempted to inject 0.375% anapeine using a 20cc syringe, he/she was unable to inject it.Therefore, the catheter was replaced with a new kit.
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Search Alerts/Recalls
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