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

Model Number	101/860/085CZ
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2022-11661
• Device Sequence Number: 4855527
• Product Code: BTO
• UDI-Device Identifier: 15019517076165
• UDI-Public: 15019517076165
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown