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

Model Number	101/811/070
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the flange was broken.The tube had been used by the patient for three (3) weeks when it broke.No adverse patient effects were reported by the customer.There are three reported events under (b)(6) and all involve the same patient.Only one patient is involved in these three events.
Additional Manufacturer Narrative
Other text: b3: date of event is unknown, no 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.
Additional Manufacturer Narrative
Other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Three (3) unused and one (b)(4) used device were returned for investigation.Under visual inspection it was noticed that the used tracheostomy tube had a broken flange as described by the customer.The three (b)(4) unused tracheostomy tubes were found to be without any defect even when the flange was several times bent and pulled.Due to fact that the product was in use for three (3) weeks it is highly improbable that the failure happened during manufacturing.Any similar customer complaint where the customer described such broken flange was not identified therefore this incident was considered an isolated incident with unknown root cause.A device history record (dhr) review showed there were no observations recorded during manufacturing to suggest an issue of this nature would occur with this lot of products.No action taken.

• 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: 17231598
• Report Number: 3012307300-2023-06896
• Device Sequence Number: 12531675
• Product Code: BTO
• UDI-Device Identifier: 15019517076356
• UDI-Public: 15019517076356
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: Lay User/Patient
• Device Model Number: 101/811/070
• Device Catalogue Number: 101/811/070CZ
• Device Lot Number: 4252499
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/19/2023
• 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: 06/14/2023
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• 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