Catalog Number ASK-05500-KM |
Device Problems
Leak/Splash (1354); Cut In Material (2454)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/17/2016 |
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.The manufacturer will continue to monitor and trend related events.
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Event Description
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Alleged event: the user found a solution leaking from the catheter.The user stopped using it because a crack was found on the catheter.As a result the catheter was replaced by a new one.The patient's condition was reported as fine.
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Manufacturer Narrative
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(b)(4).The customer reported the catheter was leaking.The customer returned one snaplock adapter with clamp, one flat filter, and one epidural catheter.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 filter revealed that the filter appears typical with no observed defects or anomalies.Visual examination of the returned snaplock adapter revealed that the snaplock adapter appears typical with no observed defects or anomalies.Visual examination of the returned epidural catheter revealed that the catheter is used as adhesive material can be seen on the outer extrusion.The coils appear to be offset at approximately 22cm (ruler (b)(4)) from the distal.No other defects or anomalies were observed.A functional leak test was performed per mrq 000017 section 6.5; rev 5 using the returned catheter and the returned snaplock adapter.The returned catheter was inserted into the snaplock adapter until it bottomed out and the components were then connected to the lab leak tester ((b)(4)).The pressure was set at 10 psi to establish flow.The catheter was found to leak immediately at approximately 22cm from other remarks: the distal end.This is the location where the coils were offset.Microscopic examination revealed a cut of the extrusion was observed at the same location.The distal end of the catheter was capped off and the pressure was increased to 25 psi for 30 seconds.No additional leaks were detected.A corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause.All epidural catheters are tested for leaks at the time of manufacturing.A device history record review performed on the epidural catheter showed no evidence to suggest a manufacturing related cause.The leak was detected during use.Therefore, based on the condition of the sample received and the time of discovery indicate operational context caused or contributed to this event.
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Event Description
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Alleged event: the user found a solution leaking from the catheter.The user stopped using it because a crack was found on the catheter.As a result the catheter was replaced by a new one.The patient's condition was reported as fine.
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Search Alerts/Recalls
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