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

Model Number	101/815/070
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the length of the inner cannula exceeded the length of the trach leaving a sharp edge to come in contact with the patients trachea.No patient injury was reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4).As a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.One picture was attached.During the analysis conducted, it could be observed the back side of the packaging product; however, there is not evidence regarding to the failure mode reported.Both cannulas received were inserted into tracheostomy tube and it was observed that cannula overpass the length tube; thus, the failure mode reported is confirmed.The root cause of the reported issue was able to be determined as supplied item.Actions were taken to mitigate the reported issue: supplier started a project to replace the existing 2 cavity.No problems or issues were identified during this device history record review.

• Brand Name: PORTEX TUBES BLUSELECT TRACHEOSTOMY
• 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: 17049220
• Report Number: 3012307300-2023-05962
• Device Sequence Number: 20599836
• Product Code: BTO
• UDI-Device Identifier: 15019517077346
• UDI-Public: 15019517077346
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2023

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: 101/815/070
• Device Catalogue Number: 101/815/070
• Device Lot Number: 4021058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown