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

Lot Number 200109

Device Problem Break (1069)

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

Event Date 03/01/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site address is unknown.Catalog number is unknown.Udi information is unknown.Premarket (510k) number is unknown.A sample was received to perform an investigation.A broken piece of the connector caps was returned.A visual inspection of the device observed the fracture surface (near the base of the cap) was uneven.A device history record (dhr) review was performed and found no discrepancies or anomalies.From inspection of the fracture surface of the fragment, it is possible that the cap was damaged due to a load being applied to this location.Manufacturing has been notified of this occurrence.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

Event Description

It was reported that after connecting the epidural catheter to the connector, the user conducted a test dose of medical fluid, and the syringe was unable to be connected to it.The connector was checked and it was found that a part of the cap broke off and it remained inside the connector.No patient injury was reported.

• Brand Name: EPIFUSE CATHETER CONNECTOR
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15322692
• MDR Text Key: 305265201
• Report Number: 3012307300-2022-16839
• 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 Lot Number: 200109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2022
• 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