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 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

No lot number was provided; therefore, device history record review could not be performed.A product sample was received for evaluation.Functional testing was performed.Functional testing found returned sample was rejected, since the edge of the product did not reach the luer tape limits after applying 3.5 kg force.The root cause is related to a supplier issue since the defective component is a component.Inspection level for raw material was increased from normal to tightened on (b)(6) 2020 and no similar defects have been reported after implementation of corrective actions.Personnel were notified of this complaint 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 during a pre-use check, the customer attempted to connect the product to 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: 15360483
• MDR Text Key: 305164922
• Report Number: 3012307300-2022-17820
• 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: Non-Healthcare Professional
• 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 Catalogue Number: 100/594/000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 09/06/2022
• 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