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

Model Number 101/860/080

Device Problems Defective Component (2292); Connection Problem (2900)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Month and year of event have been provided; day is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Event Description

It was reported that during the use of the product, the customer noticed the diameter of the one-way valve was smaller than usual, and he found difficulty connecting the product to a syringe.No patient injury reported.No additional information is available for this complaint.

Manufacturer Narrative

Other text: h6: event methods, evaluation, and conclusion codes: updated.One used device was received for investigation.Under visual inspection the sample appeared to be in good condition.The reported issue was confirmed during functional testing when luer slip syringes could not be connected with returned complaint sample pilot balloon connector.During manufacturing process each tracheostomy tube is connected several times via pilot balloon connector to air supply.It was found that it is not possible to connect returned pilot balloon connector with air supply luer slip connectors which are used in production.Based on that it is not possible that product left smiths medical (icu medical) in such conditions.Review of complaint data indicated that only one other instance of the reported issue has been previously recorded.A review of the manufacturing device history records for the reported lot showed there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.Based on the available information and device analysis, the complaint was confirmed, but a root cause could not be attributed.

• Brand Name: PORTEX BLU SELECT SUCTIONAID TRACHEOSTOMY TUBE
• 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: 16541807
• MDR Text Key: 311291612
• Report Number: 3012307300-2023-02435
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076158
• UDI-Public: 15019517076158
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/080
• Device Catalogue Number: 101/860/080CZ
• Device Lot Number: 4281081
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/28/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1