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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT NRFIT
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EPIDURAL CATHETERIZATION KIT NRFIT Back to Search Results
Catalog Number ASK-05500-KM
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/29/2020
Event Type  malfunction  
Manufacturer Narrative
(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 leakage was found from the connection point of the snaplock adaptor and the catheter during placement.Therefore, the catheter and the snaplock adaptor were removed and replaced with a new kit.
 
Manufacturer Narrative
Qn#(b)(4).A lot number was not 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 snaplock assembly and epidural catheter with no relevant findings.The customer reported there was a leak at the connection of the snaplock and catheter.The customer returned one snaplock assembly and one epidural catheter.The returned components were received connected together (reference attached files inp1900077420).The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock assembly appear typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears used as biological material can be seen on the inner coils and adhesive can be seen on the outer extrusion.No other defects or anomalies were observed.A functional flow test was performed on the returned snaplock assembly and epidural catheter per amrq-000017 section 7.8; rev.7.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.The snaplock assembly was connected to the lab leak tester (ref-002902) and the pressure was increased to 10 psi to establish flow.Water could be seen immediately exiting the distal end of the catheter.The distal end of the catheter was then capped off and the pressure was increased to 25 psi for 30 seconds (ref-003150).No leak was detected.A corrective action is not required at this time as there were no functional issues found with the returned sample.The reported complaint of a leak coming from the connection of snaplock and catheter could not be confirmed based on the sample received.A lot number was not 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 snaplock assembly and epidural catheter with no evidence to suggest a manufacturing related issue.The returned snaplock assembly and epidural catheter passed a functional leak test.Therefore, based on this, there were no functional issues found with the returned sample.
 
Event Description
It was reported that leakage was found from the connection point of the snaplock adaptor and the catheter during placement.Therefore, the catheter and the snaplock adaptor were removed and replaced with a new kit.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT NRFIT
MDR Report Key10159433
MDR Text Key195901351
Report Number3006425876-2020-00522
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 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberASK-05500-KM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2020
Date Manufacturer Received07/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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