MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION SET NRFIT

Catalog Number EJ-05400-NRON

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

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 medical agent could not be injected through the catheter in the middle.Therefore, a new kit was used instead.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter would not inject medication.The customer returned one snaplock assembly nrfit and one epidural catheter.The returned components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed 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 sample 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 flow rate was measured at 8.4ml/min (stopwatch: ref-003150), which is within the specification of 1ml/min.No blockages were found.A corrective action is not required at this time as there were no functional issues found with the returned sample.The reported complaint of the catheter not injecting medication could not be confirmed based on the sample received.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The returned components passed a functional flow test and met flow rate specifications.There were no functional issues found with the returned sample.

Event Description

It was reported that the medical agent could not be injected through the catheter in the middle.Therefore, a new kit was used instead.

• Brand Name: EPIDURAL CATHETERIZATION SET NRFIT
• MDR Report Key: 10473415
• MDR Text Key: 206135445
• Report Number: 3006425876-2020-00740
• 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: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2022
• Device Catalogue Number: EJ-05400-NRON
• Device Lot Number: 71F20A2040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2020
• 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