MAUDE Adverse Event Report: NULL PORTEX ANESTHESIA ACCESSORIES AND CONNECTORS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/594/000

Device Problem Connection Problem (2900)

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

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found no discrepancies in the returned sample.Functional testing found the swivel fails the minimum insertion depth test.The possible root causes are: raw material is out specification by supplier and/or the iso test method is ambiguous.The following actions were taken: quality alert 100% inspection of all material iso tests, create visual aid where specifies the iso test method and supplier notified on (b)(6) 2020.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that immediately after starting to use the product, the customer attempted to connect the product with a tracheostomy tube, but could not do it successfully.No patient injury was reported.

• Brand Name: PORTEX ANESTHESIA ACCESSORIES AND CONNECTORS
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section G): NULL
• MDR Report Key: 15361699
• MDR Text Key: 305599735
• Report Number: 3012307300-2022-17864
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173912
• 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: 09/06/2022

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 Expiration Date: 04/05/2024
• Device Catalogue Number: 100/594/000
• Device Lot Number: 3786881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1