Catalog Number ASK-05502-FH1 |
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 06/15/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.
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Event Description
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Could not infuse through our flex-tip plus catheter contained in the kit.There was no patient injury.
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Manufacturer Narrative
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(b)(4).No lot number was provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter would not infuse.The customer returned one epidural catheter and one snaplock adapter.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 but used.Adhesive material can be seen on the outer extrusion of the catheter.No other defects or anomalies were observed.A manual flow test was performed using the returned catheter and snaplock adapter.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.Other remarks: the reported complaint of the catheter not being able to infuse could not be confirmed based on the sample received.No lot number was provided.A device history record review was performed based upon a lot number from sales history data with no evidence to suggest a manufacturing related cause.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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Could not infuse through our flex-tip plus catheter contained in the kit.There was no patient injury.
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Search Alerts/Recalls
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