MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION SET NRFIT

Catalog Number EJ-05400-NRON

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the user was unable to connect other company's syringe to the snaplock adaptor properly.Therefore, he/she removed the catheter with snaplock adaptor and replaced with a new kit.

Manufacturer Narrative

(b)(4).A device history record review was performed on the snaplock assembly with no relevant findings.The customer reported the snaplock assembly would not connect to a non-teleflex syringe.The customer returned one non-teleflex glass lor syringe, one snaplock assembly nrfit, one epidural catheter, and one outer tray (reference attached files inp1900081050).The returned snaplock and catheter 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.No other defects or anomalies were observed.Functional testing was performed on the returned sample.The returned non-teleflex glass lor syringe was an nrfit slip connection.The returned snaplock assembly is a nrfit lock connection.Based on this, the snaplock can only be connected to nrfit lock components.The returned snaplock assembly was connected to a lab inventory injection syringe nrfit lock connection with no issues.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 snaplock assembly not connecting to a non-teleflex syringe could not be confirmed based on the sample received.The customer returned a non-teleflex glass lor syringe nrfit and a snaplock assembly nrfit.The non-teleflex lor syringe is a nrfit slip connection and the snaplock assembly can only be connected to components with nrfit lock connections.The returned snaplock assembly was connected to a lab inventory injection syringe with an nrfit lock connection with no issues.A device history record review was performed on the snaplock assembly with no evidence to suggest a manufacturing related issue.Based on this, there were no functional issues found with the returned snaplock assembly.

Event Description

It was reported that the user was unable to connect other company's syringe to the snaplock adaptor properly.Therefore, he/she removed the catheter with snaplock adaptor and replaced with a new kit.

• Brand Name: EPIDURAL CATHETERIZATION SET NRFIT
• MDR Report Key: 10961533
• MDR Text Key: 220442333
• Report Number: 3006425876-2020-01018
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2022
• Device Catalogue Number: EJ-05400-NRON
• Device Lot Number: 71F20E1666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Date Manufacturer Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2020
• 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