MAUDE Adverse Event Report: PORTEX; ANESTHESIA CONDUCTION KIT

Catalog Number 100/391/116CZ

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2019

Event Type  malfunction  

Event Description

It was reported that the catheter broke during removal.The clinician attempted another space, however the desired length of catheter could not be inserted.The clinician abandoned the procedure as a result.This incident occurred during induction.No patient injury or complications were reported in relation to this event.

Manufacturer Narrative

The investigation of the complaint was limited because no sample was returned.The complaints trend review identified that there is no trend of confirmed complaints in relation with this issue.Due to the fact that reported issue occurred during procedure it is the most probable that the catheter was cut off by tuohy needle when catheter was pulled back which is in conflict with ifu l6306 rev.100, page 4, point 4.1: "never pull back the catheter through the epidural tuohy needle as this can result in the catheter being cut and left in the epidural space.If catheter insertion difficulties are encountered, the epidural tuohy needle and catheter should be removed carefully together as a single unit, and the procedure repeated." the problem source of the reported product problem was unknown.A root cause was not established.

• Brand Name: PORTEX
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 8917277
• MDR Text Key: 155101527
• Report Number: 3012307300-2019-04212
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Catalogue Number: 100/391/116CZ
• Device Lot Number: 3138613
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1