MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE

Model Number	198-32L
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use, the cuff was found damaged and leaking.No patient injury.No additional information is available for this complaint.
Additional Manufacturer Narrative
Other, other text: one device was received and visual inspection found damage to the cuff.The most probable root cause is related to damage that occurred during insertion, either from instrumentation or patient teeth.The device was leaking due to the damage, and in its condition would not pass through manufacturing processing.Additionally, according to the instructions for use (b)(6) rev.100: warnings, section 4.1.Both the tracheal and bronchial cuff inflation systems should be tested for function and leaks before intubation.Cuff leaks that are detected immediately following tube placement are usually due to cuff nicks from teeth or instrumentation during intubation.True cuff leaks may require reintubation and placement of a new endobronchial tube.A review of the dhr did not find any deviations or issues noted during manufacture- all required inspections were completed prior to release.

• Brand Name: PORTEX
• Common Device Name: TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: david halverson ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 12512368
• Report Number: 3012307300-2021-09522
• Device Sequence Number: 17151715
• Product Code: CBI
• UDI-Device Identifier: 15019315058608
• UDI-Public: 15019315058608
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K953483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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 Model Number: 198-32L
• Device Lot Number: 4042247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown