Catalog Number ASK-05500-KM |
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 11/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (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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It was reported that the medical agent did not flow into the catheter smoothly.The user doubted the catheter being blocked, so replaced it with a new one.
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Event Description
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It was reported that the medical agent did not flow into the catheter smoothly.The user doubted the catheter being blocked, so replaced it with a new one.
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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.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 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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It was reported that the medical agent did not flow into the catheter smoothly.The user doubted the catheter being blocked, so replaced it with a new one.
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Manufacturer Narrative
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Qn#(b)(4).The customer reported the catheter was blocked.The customer returned one snaplock assembly and one epidural catheter.The returned 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 assembly revealed the snaplock assembly appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used.Adhesive material can be seen on the outer extrusion of the catheter.A functional flow test was performed on the returned sample per (b)(4) section 7.8; rev.7.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 (c05176) 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 9.0ml/min (c05180), which is within the specification of 1ml/min.No blockages were found.The reported complaint of the catheter being blocked 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.
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Search Alerts/Recalls
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