MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION SET NRFIT

Catalog Number EJ-05400-NRON

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2021

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 medical agent leaked from snaplock adaptor during use on a patient.Therefore, the user removed the catheter with snaplock adaptor and replaced with a new kit.

Event Description

It was reported that the medical agent leaked from snaplock adaptor during use on a patient.Therefore, the user removed the catheter with snaplock adaptor and replaced with a new kit.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the snaplock assembly with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the snaplock assembly with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of the snaplock leaking could not be determined based upon the information provided and without a sample.

• Brand Name: EPIDURAL CATHETERIZATION SET NRFIT
• MDR Report Key: 11372079
• MDR Text Key: 234752122
• Report Number: 3006425876-2021-00169
• 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: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2022
• Device Catalogue Number: EJ-05400-NRON
• Device Lot Number: 71F20E1665
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2020
• 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