MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT NRFIT

Catalog Number OU-05500-NRON

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2020

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 the user found leakage from the filter while in use.Therefore, the catheter was removed and replaced with a new kit.

Event Description

It was reported that the user found leakage from the filter while in use.Therefore, the catheter was removed and replaced with a new kit.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the flat filter with no relevant findings.The customer reported the flat filter leaked during use.The customer returned one snaplock assembly nrfit, one flat filter nrfit, and a catheter piece.The components were received connected together.The returned components were visually examined with and without magnification.Visual exanimation of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned filter revealed the filter appears typical with no observed defects or anomalies.Functional inspection was performed on the returned sample.A functional leak test was performed per amrq-000017 section 7.5 rev.7 using the returned filter and snaplock assembly with the lab leak tester ((b)(4)).The returned snaplock assembly was connected to the male lock connector of the returned filter and hand tightening the rotating collar to the snaplock assembly with no issues.A lab 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 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 (stopwatch: (b)(4)).No leak was detected.A corrective action is not required at this time as no issues were found with the returned sample.The reported complaint of the filter leaking could not be determined based on the sample received.During functional inspection, no leak was detected.A device history record review was performed on the filter with no relevant findings.Therefore, no issues were found with the returned sample.

• Brand Name: EPIDURAL CATHETERIZATION KIT NRFIT
• MDR Report Key: 10359050
• MDR Text Key: 202580120
• Report Number: 3006425876-2020-00650
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2022
• Device Catalogue Number: OU-05500-NRON
• Device Lot Number: 71F20A2729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1