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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION SET NRFIT
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EPIDURAL CATHETERIZATION SET NRFIT Back to Search Results
Catalog Number EJ-05400-NRON
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the catheter was disconnected from the snaplock adaptor.The catheter and the adaptor were removed and replaced with a new kit.According to the user, he/she felt it difficult to lock the snaplock adaptor when connecting it to the catheter.
 
Manufacturer Narrative
(b)(4).The customer reported that the snaplock assembly disconnected from the catheter.The customer returned one snaplock assembly nrfit and epidural catheter.The components were received connected together.The returned snaplock assembly was visually examined with and without magnification.The snaplock assembly appears typical with no defects or anomalies observed.Visual examination of the returned epidural catheter revealed that the catheter appears used.Biological material can be seen between the catheter coils and adhesive residue is present on the catheter body exterior.Also, the returned catheter was tied into a knot at approximately 95mm (ruler: 10171599) from the proximal end.No other defects or anomalies were observed.A functional leak test was performed on the returned snaplock assembly and epidural catheter per amrq-000017 section 7.5; rev.8.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.It should be noted, the returned catheter was still tied into a knot, but did not impact functional testing.The snaplock assembly was connected to the lab leak tester (ref-002902) 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 (stopwatch: ref-003150).No leaks were detected, and the components remained secured.A functional spontaneous partial opening (spo) test was then performed per amrq-000017 section 7.7; rev 8.The proximal end of the epidural catheter was re-inserted into the snaplock assembly until it bottomed out and the snaplock assembly 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 assembly was confirmed to have remained securely locked with the catheter inserted.No functional issues were found.A device history record review was performed on the epidural catheter and snaplock assembly with no relevant findings.No corrective action needed at this time since no functional issues were found with the returned snaplock assembly.The reported complaint of the snaplock assembly disconnecting from the catheter could not be confirmed through functional testing of the returned snaplock assembly.The snaplock assembly was secured to the returned epidural catheter and passed the functional tests performed including a spontaneous partial opening (spo) test.A device history record review was performed on the epidural catheter and snaplock assembly with no relevant findings.Therefore, based on function testing of the sample, no problem found with the returned snaplock assembly.
 
Event Description
It was reported that the catheter was disconnected from the snaplock adaptor.The catheter and the adaptor were removed and replaced with a new kit.According to the user, he/she felt it difficult to lock the snaplock adaptor when connecting it to the catheter.
 
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Brand Name
EPIDURAL CATHETERIZATION SET NRFIT
MDR Report Key10792577
MDR Text Key217438126
Report Number3006425876-2020-00936
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 10/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/24/2022
Device Catalogue NumberEJ-05400-NRON
Device Lot Number71F20E1333
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2020
Date Manufacturer Received12/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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