MAUDE Adverse Event Report: NULL PORTEX EPIDURAL MINIPACKS; ANESTHESIA CONDUCTION KIT

Catalog Number 100/391/116CZ

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Manufacturer Narrative

A sample was received to perform an investigation.Visual inspection found that the luer lock connector was separated from filter body.Each flat filter has retention ring which is designed to hold luer lock connected with filter.Retention ring and luer lock connector on the sample were found to be without any damage.Retention ring and luer lock hole diameters were measured under camera system.It was found that retention ring was slightly undersized and luer lock hole diameter was within specification.Undersized retention ring might cause reported luer lock connector detachment without using of excessive force.A device history review (dhr) could not be performed as the lot number was unknown.Due to this finding, supplier corrective action request (scar) was issued against the supplier.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the luer locking mechanism on the epidural filter came off the filter and loosened connection to the connector.Per anesthetists, they have not been overtightening lock.No patient injury was reported.

• Brand Name: PORTEX EPIDURAL MINIPACKS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15322385
• MDR Text Key: 305367202
• Report Number: 3012307300-2022-16831
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K965017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/391/116CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1