MAUDE Adverse Event Report: NULL PORTEX ENDOTRACHEAL TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number NCE6344JP

Device Problem Connection Problem (2900)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Review of manufacturing records, relevant to the lot reported, found no discrepancies or anomalies.One flat filter was returned.As a result of observing the flat filter, it was confirmed that the female connector was deformed into an ellipse and the connector could not be connected at all.This event may have been deformed during the filter manufacturing process at the supplier, but the cause and timing of the occurrence could not be identified.The reported event was confirmed.The root cause was not identified.The manufacturing department will be notified of the occurrence of this event.The event will be recorded in the database and monitored for future occurrence situation.The supplier was also notified of this event.Review of manufacturing records, relevant to the lot reported, found no discrepancies or anomalies.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

Event Description

It was reported that during the use of the product, the customer noticed the diameter of filter on the infusion side was larger than usual, which did not allow connection to a mating component properly.No patient injury was reported.

• Brand Name: PORTEX ENDOTRACHEAL TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section G): NULL
• MDR Report Key: 15322267
• MDR Text Key: 305385224
• Report Number: 3012307300-2022-16821
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2022

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 Catalogue Number: NCE6344JP
• Device Lot Number: 201006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 08/30/2022
• 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