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

Catalog Number	101/815/080
Medical Device Problem Codes	Material Puncture/Hole (1504); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: primary udi is unknown because the product item number was not provided.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 there was some air in pilot balloon.Withdrew 4 cc of air using 10 cc syringe.Trach was removed with no incident to patient.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
One device was received for investigation.The reported issue was confirmed during functional testing when the reported inflation issue was duplicated.The issue was traced to the device balloon, which was observed to have a hole.Manufacturing device history record review was not performed because no lot number was provided.Complaint information will continue to be monitored.

• Brand Name: PORTEX BLUSELECT TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20030587
• Report Number: 3012307300-2024-07927
• Device Sequence Number: 7335712
• Product Code: BTO
• UDI-Device Identifier: 15019517077360
• UDI-Public: (01)15019517077360
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 101/815/080
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 01/29/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown