MAUDE Adverse Event Report: NULL PORTEX; ANESTHESIA CONDUCTION KIT

Model Number NCE6401JP

Device Problem Leak/Splash (1354)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

Returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

Event Description

It was reported that during the use of the product, leakage of medical fluid from the connector was observed.No patient injury.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated after device evaluation h10: device evaluation: the epifuse connector was returned for investigation.A visual inspection and functional test were performed.Visual inspection results: as a result of observing the sample, no abnormality was found.Functional testing: a stock catheter was connected and water was injected with a syringe, but water flowed normally and no liquid leakage was observed.Conclusion: the reported event was not confirmed.The cause of the reported problem could not be determined.Dhr review was completed: review of manufacturing records, relevant to the lot reported, found no discrepancies or anomalies.

• Brand Name: PORTEX
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 12311116
• MDR Text Key: 266152820
• Report Number: 3012307300-2021-08334
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NCE6401JP
• Device Catalogue Number: NCE6401JP
• Device Lot Number: 210325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 08/10/2021; 06/14/2023
• Supplement Dates FDA Received: 03/10/2022; 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1