Catalog Number ASK-05500-KM |
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 04/17/2018 |
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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It was reported that the medical agent was unable to be injected through the catheter during use although there was no issue found during flushing test.As a result, it was replaced by a new one.After the catheter was removed from the patient, the user injected saline solution into it.There was no patient injury.
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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 medication would not inject through the catheter.The customer returned one non teleflex 5ml luer slip syringe, one epidural catheter, one flat filter, and one snaplock adapter with clip.The components were received connected together (reference files pic_inp1900060152).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 filter revealed that the filter 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 and biological material can be seen between the inner coils.No other defects or anomalies were observed.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 adapter until it bottomed out and the snaplock adapter was other remarks: closed.The components were confirmed to be secured by tugging gently.The snaplock adapter 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 8.4ml/min (c05180), which is within the specification of 1ml/min.No blockages were found.The reported complaint of the catheter not being able to inject 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.
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Event Description
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It was reported that the medical agent was unable to be injected through the catheter during use although there was no issue found during flushing test.As a result, it was replaced by a new one.After the catheter was removed from the patient, the user injected saline solution into it.There was no patient injury.
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Search Alerts/Recalls
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