MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BLUSELECT 8.0, REPLACEMENT INNER CANNULA, NON-FEN, 50/BX; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/858/080
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
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 cannula was not clicking into place inside the trach and can slide right out.There was patient involvement and no adverse event reported.
Additional Manufacturer Narrative
D9.Date returned to mfg: 17-sep-2024.G1.Contact office email: corrected.H6.Component code: updated.Investigation summary: one (1) returned sample of p/n 101/858/080 from lot: 4442599 was received in unused condition and in its original packaging.The returned sample was visually inspected at 12¿ to 16¿ and normal conditions of illumination.Per visual inspection, no damage was identified in the sample returned.A ring gauge test was performed on the sample to verify the external diameter ¿click fit od - over bumps¿.Sample failed the ¿minimum¿ ring gauge test.Failure mode reported: ¿a0266 - inner cannula problem¿ was confirmed.The root cause was a supplier issue, inner cannula part number 10001190-001 was found to have a burr on the gate of the cavity.Supplier inspection procedure not clear, it only included the tool that needed to be used, but did not include a method/inspection criterion.Action taken: scar (supplier corrective action request) snn-00004792 was opened on october 31 to the supplier of component part number p/n 10001190-001 to address the click fit od out of spec condition.The scar was closed with the following actions taken: 1.The tool was repaired to eliminate burr on the gate of cavity 2.Inspection procedure was updated to add detailed instructions for the use of the inspection gage and add acceptance criteria 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.

• Brand Name: BLUSELECT 8.0, REPLACEMENT INNER CANNULA, NON-FEN, 50/BX
• 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 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20251879
• Report Number: 9617604-2024-00727
• Device Sequence Number: 8516951
• Product Code: BTO
• UDI-Device Identifier: 15019517077865
• UDI-Public: (01)15019517077865(17)281205(10)4442599
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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: 101/858/080
• Device Lot Number: 4442599
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 12/23/2024
• 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