MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BLUSELECT REPLACEMENT INNER CANNULA; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/856/080
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the inner cannulas does not click in and pops out.Patient involvement and adverse patient effects are unknown/unclear.
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.
Additional Manufacturer Narrative
Investigation summary: twenty (20) returned samples of p/n 101/856/080 from lot: 4435050 were received in unused condition and in their original packaging.The returned samples were visually inspected at 12¿ to 16¿ and normal conditions of illumination according.Per visual inspection, no damage was found in the samples returned.A bluselect tracheostomy tube of the same size as the samples returned by the customer was taken and the cannulas were inserted.All returned samples were tested.All samples were well adjusted; no damage was found in the returned samples.The failure mode of ¿a0266 - inner cannula problem¿ was not confirmed.Based on the analysis conducted in the sample provided, no root cause was determined.No actions were required since the complaint was not confirmed.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
Device evaluation: twenty samples were returned in unused conditions in original packaging.Per visual inspection, no damage was found in the samples returned.During the functional testing, all samples failed the minimum ring gauge test.The failure mode was able to be confirmed.The root cause was found to be that the od over bumps were out of specification due to the flash on the supplier tool.The supplier mold was repaired to remove the burr on cavity number 2.The supplier updated the inspection test method to align with the icu medical method.A retrospective review of 12-month period was made for complaints originated and related to this issue and three additional complaints (b)(4) were identified to this lot 4435050.

• Brand Name: PORTEX BLUSELECT REPLACEMENT INNER CANNULA
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19260641
• Report Number: 3012307300-2024-03454
• Device Sequence Number: 6680328
• Product Code: BTO
• UDI-Device Identifier: 15019517077797
• UDI-Public: (01)15019517077797(17)281001(10)4435050
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2025

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: 4435050
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 05/24/2024; 03/06/2025
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/27/2024; 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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