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

Model Number	101/817/070
Medical Device Problem Codes	Difficult to Insert (1316); Defective Component (2292); Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: 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 or Problem Description
It was reported that during use with a patient the trach "felt heavy in opening and dragged down.The stoma felt sore feels heavier than previous trach flange maybe a little shorter.Flakes of green markings came off on skin strap; poor quality.".
Additional Manufacturer Narrative
Evaluation codes: updated.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• 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: 17010142
• Report Number: 3012307300-2023-05719
• Device Sequence Number: 15342167
• Product Code: BTO
• UDI-Device Identifier: 15019517077483
• UDI-Public: 15019517077483
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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: Other
• Device Expiration Date: 10/13/2025
• Device Model Number: 101/817/070
• Device Catalogue Number: 101/817/070
• Device Lot Number: 3986585
• Was Device Available for Evaluation?: No
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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