MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION SET NRFIT

Catalog Number EJ-05400-NRON

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2020

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 snaplock adaptor did not function normally during use on a patient.Therefore, the user removed the catheter with snaplock adaptor and replaced with a new kit.

Manufacturer Narrative

(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 with no relevant findings.The customer reported that the snaplock assembly was not functioning properly.The customer returned one snaplock assembly nrfit and one epidural catheter.The returned components were received connected together (reference attached files (b)(4)).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.No other defects or anomalies were observed.Functional inspection was performed on the returned snaplock assembly.The returned catheter would insert into the returned snaplock assembly until it bottomed out with no difficulty.The returned snaplock assembly would open and close typically with and without a catheter fully inserted.A manual flow test was performed on the returned snaplock assembly and catheter with a lab inventory syringe.No flow issues were observed.With a lab inventory syringe, a manual leak test was also performed on the returned snaplock assembly with the returned epidural catheter and a closed snaplock adapter.Water was injected into the snaplock and no leaks were observed.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 was not functioning normally 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 with no evidence to suggest a manufacturing related issue.The returned snaplock assembly opened and closed typically with and without a catheter fully inserted and passed a functional flow and leak testing.There were no functional issues found with the returned sample.

Event Description

It was reported that the snaplock adaptor did not function normally during use on a patient.Therefore, the user removed the catheter with snaplock adaptor and replaced with a new kit.

• Brand Name: EPIDURAL CATHETERIZATION SET NRFIT
• MDR Report Key: 10114731
• MDR Text Key: 194315829
• Report Number: 3006425876-2020-00515
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EJ-05400-NRON
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Date Manufacturer Received: 07/09/2020
• 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 Number: 1
• Patient Outcome(s): Required Intervention