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

Model Number	101/816/070
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.Based on information provided by supplier the most probable root cause it that current low capability in the tooling for injection mold tools for sizes 8mm and 7mm twic (thin wall inner cannula).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: 17049353
• Report Number: 3012307300-2023-05963
• Device Sequence Number: 11632891
• Product Code: BTO
• UDI-Device Identifier: 15019517077414
• UDI-Public: 15019517077414
• 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: 101/816/070
• Device Catalogue Number: 101/816/070
• Device Lot Number: 3965216
• 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