MAUDE Adverse Event Report: NULL EPIFUSE EPIDURAL CATHETER CONNECTOR; ANESTHESIA CONDUCTION KIT

Catalog Number NCE6604JP

Device Problem Material Separation (1562)

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

Event Date 12/01/2020

Event Type  malfunction  

Event Description

It was reported that during the use of the product, the hinge part of the connector broke.No patient injury was reported.

Manufacturer Narrative

A sample was received to perform an investigation.A visual inspection of the device confirmed that the hinge was broken.In manufacturing, 100% inspection was performed on the appearance of the connectors before setting.Therefore, it seems that the hinge part cracked and damaged when using the epifuse connector.The cause and timing of occurrence were not identified.The root cause is likely due to the molding design of the product.A device history review (dhr) could not be performed as no lot number was available.Due to this information a supplier corrective action request (scar) was issued against supplier.Model#, catalog #, serial #, lot#, expiration date, other #, udi# , operator of device, mfr site and 510(k) are unknown.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

• Brand Name: EPIFUSE EPIDURAL CATHETER CONNECTOR
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15322753
• MDR Text Key: 305267622
• Report Number: 3012307300-2022-16844
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• 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: Other
• Device Catalogue Number: NCE6604JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2022
• 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