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

Catalog Number	101/856/080
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).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 during a routine cannula change the cannula would not "click" in.There was patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
Investigation summary: one sample returned sample 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 on the sample returned.A ring gauge test was performed to verify the external diameter ¿click fit od - over bumps¿.The sample failed the ¿minimum¿ ring gauge test.Failure mode reported: ¿a0266 - inner cannula problem¿ was confirmed.The inner cannula gauge was found to be defective/out of spec.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: PORTEX BLUSELECT REPLACEMENT INNER CANNULA
• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20027508
• Report Number: 9617604-2024-00660
• Device Sequence Number: 12909167
• Product Code: BTO
• UDI-Device Identifier: 15019517077797
• UDI-Public: (01)15019517077797(17)280911(10)4411403
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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: 101/856/080
• Device Lot Number: 4411403
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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