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

Model Number 101/860/085CZ

Device Problem Disconnection (1171)

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

Event Date 05/01/2022

Event Type  malfunction  

Manufacturer Narrative

A sample was received to perform an investigation.A visual inspection of the returned device, found that the suction connector was disconnected from the suction tube.The reported problem was confirmed through visual inspection.This was determined to be a supply item issue.The root cause was unable to be determined.The affected component was shipped for a secondary investigation.Operator of device is unknown.No product information has been provided to date.

Event Description

It was reported that when the customer performed a suction through the upper part of the cuff during use, the connector at the end of the suction line detached.No additional information was available.No patient injury was reported.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.According to the photos provided, it was confirmed that the connector was detached from the tube in the suction line of the subassembly.The complaint was confirmed.The root cause of the reported issue was found to be the connector at the end of the suction line got detached.Actions were taken to mitigate the reported issue: customer complaint notification was performed to the production personnel as awareness to failure mode reported.

• Brand Name: PORTEX BLUSELECT ULTRA SUCTIONAIDTRACHEOSTOMY 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; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 14674832
• MDR Text Key: 294668322
• Report Number: 3012307300-2022-11661
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076165
• UDI-Public: 15019517076165
• 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: 05/11/2023

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 Operator: Health Professional
• Device Model Number: 101/860/085CZ
• Device Catalogue Number: 101/860/085CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/11/2023
• 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