MAUDE Adverse Event Report: ST PAUL PORTEX KITS OTHER; ANESTHESIA CONDUCTION KIT

Catalog Number NSE4200CJP

Device Problems Mechanical Problem (1384); Defective Component (2292)

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

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

No product information has been provided to date.This mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).A product sample was received for e-complaint.Visual and functional testing were performed.One epifuse connector was returned.As a result of observing the connector, it was confirmed that the hinge was broken.In our kit manufacturing process, 100% inspection was performed on the appearance of connectors before setting.Therefore, it seems that the hinge part cracked and damaged when using the connector.However, the cause and timing of occurrence were not identified.The reported event was confirmed.The root cause of this event had a continuous trend of occurrence and was likely due to the molding design of the product.Manufacturing will continue to monitor the complaint trends for this event.

Event Description

It was reported that during the use of the product, the connector got damaged.No patient injury was reported.

• Brand Name: PORTEX KITS OTHER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16869324
• MDR Text Key: 314566621
• Report Number: 3012307300-2023-05071
• 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: Other
• Type of Report: Initial
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NSE4200CJP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1