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

Model Number	101/860/090
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: month and year of event have been provided, day is unknown.D4: lot number, expiration date and h4: device manufacture date is unknown, no product information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that after one week of using the product, the cuff was deflating easily.The cuff was being used on an als patient.No patient injury reported.No additional information available.
Additional Manufacturer Narrative
Other text: h6: event methods, evaluation, and conclusion codes: updated.One used device was returned for investigation.The reported issue was confirmed during visual inspection, which identified a tear in the inflation line.Due to fact that cuff leak was not observed prior to use, the investigation determined that reported failure most probably occurred during tracheostomy procedure or during use due to contact with a sharp edge.No lot number was provided, therefore no review of manufacturing device history records could be conducted.The investigation attributed the root cause of the issue to user interface.No actions have been taken at this time.

• Brand Name: PORTEX BLUSELECT TRACHEOSTOMY 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16735029
• Report Number: 3012307300-2023-04086
• Device Sequence Number: 6623461
• Product Code: BTO
• UDI-Device Identifier: 15019517076172
• UDI-Public: 15019517076172
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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: 101/860/090
• Device Catalogue Number: 101/860/090CZ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/03/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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