MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINE ULTRA SUCTIONAID; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 101/860/075CZ

Device Problem Connection Problem (2900)

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

Event Date 03/01/2022

Event Type  Injury  

Event Description

It was reported that during the use of the product, the customer noticed the pilot balloon was imperfectly connected to the product, which would not allow him to put air in it properly.No patient injury.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.One used decontaminated sample was returned for investigation without its original packaging.Under visual inspection we noticed that inflation line was detached from pilot balloon.Product was assembled in tijuana therefore secondary investigation object was created with purpose to capture component investigation.Similar customer complaints have been recently received therefore internal non-conformity report (ncr) was created with purpose to evaluate this issue.Two pictures were attached, during the analysis conducted in one of the pictures it could be observed a top view of the tracheostomy product, while in the other it was focus to show the detachment between the pilot balloon and the tube; the failure mode report was confirmed.Ncr was created on 03-nov-2021, in order to perform a complete cause analysis for the failure mode reported for inflation line detached, which concluded design validation as causal factor; to expand this investigation a corrective and preventative action (capa) was originated on 31-may-2022, in order to give follow up to the investigation to determine complete cause for this failure mode.This report was documented under capa, which is current on initiation phase, however, actions taken will be addressed and implemented through capa generated on 31-may-2022.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 14220264
• MDR Text Key: 290177480
• Report Number: 3012307300-2022-06986
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076141
• UDI-Public: 15019517076141
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• 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,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/075CZ
• Device Catalogue Number: 101/860/075CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/27/2022
• Supplement Dates Manufacturer Received: 04/26/2022
• Supplement Dates FDA Received: 04/28/2023
• 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
• Patient Outcome(s): Required Intervention