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	Connection Problem (2900)
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 they had fit issues with the device.This issue was related to their previous reports where the inner cannula was not clicking in place in the trach and can slide right out.Additionally, it was stated that the defect was seen at umroi facilities when an rt highlighted the issue after he and a nurse practitioner encountered fit problems with several patients.A different lot number was found that worked for the patient, and the staff was informed.There was patient involvement and no adverse event reported.
Additional Manufacturer Narrative
G1 - contact office email and h4 - device mfg date; correction.D9: date returned to mfg.: 9/17/2024.Two unopened device samples from the reported lot number were received for evaluation.The complaint was confirmed.The cause was due to manufacturing.The manufacturing inspection procedure was updated to add detailed instructions for the use of the inspection gage and add acceptance criteria.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• 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 ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20271750
• Report Number: 9617604-2024-00744
• Device Sequence Number: 17996957
• Product Code: BTO
• UDI-Device Identifier: 15019517077865
• UDI-Public: (01)15019517077865(17)281011(10)4435055
• Combination Product (Y/N): N
• 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: 4435055
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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