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

Model Number	503070
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
While inflating cuff on the patients trach, unable to inflate the cuff and found the cuff to be blown on two separate devices.

• Brand Name: PORTEX
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 17038139
• Report Number: 17038139
• Device Sequence Number: 20593101
• Product Code: BTR
• UDI-Device Identifier: 10351688009265
• UDI-Public: (01)10351688009265
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/25/2023
• Report Date (Section F): 04/25/2023

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: Other
• Device Model Number: 503070
• Device Lot Number: 4266843
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 85 KG
• Date Report Sent to FDA: 04/25/2023