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

Catalog Number	100/136/050
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
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 the cuff won't inflate.This fault occurred before patient use/during priming.There was no patient involvement and no harm/adverse event reported.
Additional Manufacturer Narrative
One device sample was received in used condition in a plastic bag.During visual inspection no damage or other defects were detected on the sample.A functional leak test was performed, and the cuff failed to stay inflated.An occlusion was confirmed in the assembly of the inflation line to the tube.The complaint was confirmed.A root cause was not identified.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: PORTEX TRACHEAL TUBE POLAR CLEAR
• Common Device Name: TUBE, TRACHEAL (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: 19315549
• Report Number: 3012307300-2024-03711
• Device Sequence Number: 6942794
• Product Code: BTR
• UDI-Device Identifier: 15019315021053
• UDI-Public: (01)15019315021053(17)280912(10)4412412
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K931735
• 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): 06/21/2024

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: 100/136/050
• Device Lot Number: 4412412
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2023
• 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