MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT NRFIT

Catalog Number ASK-05500-NRON

Device Problem No Flow (2991)

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

Event Date 01/29/2021

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 user was unable to inject the medical agent through the catheter during use on a patient.Therefore, the catheter was replaced with a new one.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported medication could not be injected through the catheter.The customer returned one snaplock assembly nrfit, one piece of an epidural catheter, and lidstock.The returned components were received connected together (reference attached files inp1900082609).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 piece revealed the proximal end of the catheter was returned and was intact.The returned catheter piece reveals the catheter appears to have been cut at the likely most distal end.The catheter appears used as biological material can be seen between the inner coils.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter piece using a ruler (10171599).The returned catheter extrusion measures approximately 10.8cm.This indicates at least 77.7cm of the extrusion is missing as the specification for the epidural catheter indicates that the proper extrusion length of an epidural catheter is 88.5-91.5cm per graphic kz-05400-030; rev.5.A functional flow test was performed on the returned sample per amrq-000017 section 7.8; rev.8.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 likely distal end of the catheter.Specifications per graphic kz-05400-030 rev.5 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-109a; rev.7, was reviewed as a part of this complaint investigation.The ifu cautions the user," do not alter the catheter or any other kit/set component during insertion, use or removal (except as instructed).".A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and the condition of the sample received.The reported complaint of the medication not being able to inject through the catheter could not be confirmed based on the sample re ceived.The customer returned a snaplock assembly and catheter piece.The returned catheter piece was missing approximately 77.7cm of extrusion from the likely most distal end of the catheter.The catheter appears to have been cut.The returned snaplock assembly and catheter piece did pass a functional flow test.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.Therefore, based on this, this complaint investigation could not be determined based upon the information provided and the condition of the sample received.

Event Description

It was reported that the user was unable to inject the medical agent through the catheter during use on a patient.Therefore, the catheter was replaced with a new one.

• Brand Name: EPIDURAL CATHETERIZATION KIT NRFIT
• MDR Report Key: 11307411
• MDR Text Key: 232516745
• Report Number: 3006425876-2021-00159
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2022
• Device Catalogue Number: ASK-05500-NRON
• Device Lot Number: 71F20E1330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Date Manufacturer Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2020
• 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