Catalog Number EC-05400-E |
Device Problem
Material Frayed (1262)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/27/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device investigation report has not been submitted at this time.The manufacturer will continue to monitor and trend related events.
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Event Description
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After locking the snaplock adapter, it gradually loosened and resulted in catheter shedding.The catheter could not be secured and was released from the snaplock.The catheter was replaced.The patient's condition was reported as fine.
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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 adapter with no relevant findings.The customer reported that the snaplock adapter became loosened from the catheter.The customer returned one snaplock adapter, one flat filter, and one epidural catheter ((b)(4)).The returned components were received connected together.The returned components were visually examined with and without magnification.Snaplock adapter appears typical with no defects or anomalies observed.The flat filter appears typical with no defects or anomalies observed.Visual examination of the returned catheter indicated that only a portion of catheter was returned.Approximately 37cm of the catheter was returned.This is indicated by the fact the length for a typical catheter is approximately 90cm and also there are no distal marker bands visible on the returned catheter.Microscopic examination of the returned catheter indicated the proximal end appears typical.However, visual examination of the most distal end of the catheter indicates the extrusion and inner coils appear to have been cut ((b)(4)).No other defects or anomalies were observed.The customer also returned one photo of the catheter and snaplock adapter in a biohazard bag.The snaplock adapter is taped around its closure point.No other defects or anomalies were observed.Dimensional inspection of the returned snaplock adapter revealed the gap between the housing and collar when the snaplock adapter was fully closed after the spo test was performed was approximately 0.33mm (0.013") (pin gauge c05157); which is within the 0.5mm specification of remaining closed for 72hrs per amrq-000017, section 6.7; rev 5.A functional leak test was performed on the returned snaplock adapter per mrq 000017 section 6.5; rev.5.A lab inventory epidural catheter was inserted from the proximal end into the returned snaplock adapter until it bottomed out and the snaplock adapter was 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.The distal end of the catheter was capped off and the pressure was increased to 25 psi for 30 seconds.No leaks were detected and the components remained secured.A functional spo test was then performed per mrq 000017 section 6.7; rev 5.The proximal end of the epidural catheter was re-inserted into the snaplock adapter until it bottomed out and the snaplock adapter was locked.The components were confirmed to be secured by tugging gently on the catheter.The components were then left to sit for 72 hours in the locked position.After 72 hours, the snaplock adapter was confirmed to have remained securely locked with the catheter inserted.No functional issues were found ((b)(4)).No corrective action needed at this time since no functional issues were found with the returned snaplock adapter.The reported complaint of the snaplock adapter loosened from the catheter could not be confirmed through functional testing of the returned snaplock adapter.The snaplock adapter was secured to the epidural catheter and passed the functional tests performed including a spontaneous partial opening (spo) test.There was no problem found with the returned snaplock adapter.
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Event Description
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After locking the snaplock adapter, it gradually loosed and resulted in catheter shedding.The catheter could not be secured and was released from the snaplock.The catheter was replaced.The patient's condition was reported as fine.
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Search Alerts/Recalls
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