Catalog Number ASK-05500-KM |
Device Problem
No Flow (2991)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/12/2020 |
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 at the snaplock adaptor attached to the catheter.Therefore, the catheter and the snaplock adaptor were replaced with a new kit.
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Event Description
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It was reported that the medical agent did not flow at the snaplock adaptor attached to the catheter.Therefore, the catheter and the snaplock adaptor were replaced with a new kit.
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Manufacturer Narrative
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(b)(4).A device history record review was performed on the epidural catheter and snaplock assembly with no relevant findings.The customer reported that the snaplock assembly was blocked.The customer returned one 25ml injection syringe, one flat filter, one snaplock assembly, and catheter.The components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly and flat filter revealed they both components appear 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.A functional flow test was performed on the returned sample per amrq-000017 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 (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 (c05180), which is within the specification of 1ml/min.No blockages were found.The reported complaint of the snaplock being blocked could not be confirmed based on the sample received.A device history record review was performed on the epidural catheter and snaplock assembly with no evidence to suggest a manufacturing related issue.The returned snaplock assembly passed a functional flow test.There were no functional issues found with the returned sample.
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Search Alerts/Recalls
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