MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BLUSELECT 8.0, REPLACEMENT INNER CANNULA, NON-FEN; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/856/080
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the inner cannulas failed to secure to the trach.The customer mentioned that this was the second time they had noticed the issue.The first was approximately a month ago.Three boxes of 20 were involved in the event.There was unknown patient involvement and no adverse event reported.
Additional Manufacturer Narrative
Investigation summary: twenty (20) returned samples of p/n 101/856/080 from lot: 4435051 were received in unused condition and in their original packaging.The 20 returned samples were visually inspected at 12¿ to 16¿ and normal conditions of illumination.Per visual inspection, no damage was identified in any of the fifty samples returned.A ring gauge test was performed on the 20 returned samples to verify the external diameter ¿click fit od - over bumps¿.All samples failed the ¿minimum¿ ring gauge test.The customer's indicated failure was confirmed.A bluselect tracheostomy tube of the same size (8mm) as the sample returned by the customer was taken and the cannula was inserted to verify if the cannula fit correctly into the tracheostomy tube.The cannula was not correctly fitted into the tube.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
Additional Manufacturer Narrative
H6.Codes: updated.Updated investigation and root cause: twenty (20) returned samples of the same part and lot number were received in unused conditions and in its original packaging.Visual inspection: the returned samples were visually inspected, and no damage was identified in any of the samples returned.Dimensional: ring gauge test was performed to verify the external diameter ¿click fit od - over bumps¿ according to procedure.Results: all samples failed the ¿minimum¿ ring gauge test.The complaint was confirmed.The root cause was identified as outside diameter (od) over bumps out of specification to flash on supplier tool (cavity 2) action taken: supplier mold was repaired to remove burr on cavity 2.Supplier updated inspection test method to align with icu medical method.Icu medical inspection procedure released with new inspection method ¿click fit od - over bumps¿ to perform sampling during receiving inspection.A retrospective 12-month review period (aug 2023 to sep 2024) was made for complaints originated and related to this issue and one additional complaint was identified for this lot number.

• Brand Name: BLUSELECT 8.0, REPLACEMENT INNER CANNULA, NON-FEN
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20135197
• Report Number: 9617604-2024-00682
• Device Sequence Number: 6969085
• Product Code: BTO
• UDI-Device Identifier: 15019517077797
• UDI-Public: (01)15019517077797(17)281004(10)4435051
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2025

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 Catalogue Number: 101/856/080
• Device Lot Number: 4435051
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 11/19/2024; 06/30/2025
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 12/05/2024; 07/25/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown