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

Lot Number 200523

Device Problem Material Separation (1562)

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

Event Date 09/13/2020

Event Type  malfunction  

Manufacturer Narrative

A sample was received for investigation.A visual inspection confirmed that the hinge part of the connector was broken and split into two.During manufacturing process of the kit, the appearance of the connector is fully inspected for any deformation or damage before incorporating it into the kit.The following causes are possible, but the cause and timing of occurrence were not specified.The worker did not notice any damage during the inspection or hinges were cracked during transportation after shipping.A device history record (dhr) review found no discrepancies or anomalies relevant to the reported problem.A supplier corrective action request (scar) was issued to the supplier.No information has been provided to date) this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

Event Description

It was reported that during use of the product, the user noticed the connector was broken, which did not allow for the medical fluid to be administer to the patient.No patient injury was reported.

• Brand Name: EPIFUSE EPIDURAL CATHETER CONNECTOR
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15316434
• MDR Text Key: 305361225
• Report Number: 3012307300-2022-16620
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 200523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2022
• 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