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

Model Number	198-35L
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-use check, leakage of air from the cuff was observed.No patient injury was reported.
Additional Manufacturer Narrative
No lot number was provided; therefore, device history record review could not be performed.A product sample and three (3) photos were received for evaluation.Visual and functional testing were performed.Visual inspection found a cut in blue cuff in photo 3 and a cut in the blue cuff was found on the sample.Functional testing found a leak was detected in blue cuff.The root cause of the reported issue could not be determined as controls for detection were verified to detect leaks.
Additional Manufacturer Narrative
Other text: no lot number was provided; therefore, device history record review could not be performed.A product sample and three (3) photos were received for evaluation.Visual and functional testing were performed.Visual inspection found a cut in blue cuff in photo 3 and a cut in the blue cuff was found on the sample.Functional testing found a leak was detected in blue cuff.The root cause of the reported issue could not be determined as controls for detection were verified to detect leaks.
Additional Manufacturer Narrative
Other, other text: no lot number was provided; therefore, device history record review could not be performed.A product sample and three (3) photos were received for evaluation.Visual and functional testing were performed.Visual inspection found a cut in blue cuff in photo 3 and a cut in the blue cuff was found on the sample.Functional testing found a leak was detected in blue cuff.The root cause of the reported issue could not be determined as controls for detection were verified to detect leaks.

• Brand Name: PORTEX
• Common Device Name: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION
• 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: jim vegel ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 13195367
• Report Number: 3012307300-2022-00321
• Device Sequence Number: 17653965
• Product Code: CBI
• UDI-Device Identifier: 15019315058615
• UDI-Public: 15019315058615
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/05/2022

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: 198-35L
• Device Catalogue Number: 198-35L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• 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: 12/20/2021
• Supplement Date Received by Manufacturer: 08/05/2022; 08/05/2022; 08/05/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 09/03/2022; 09/03/2022; 09/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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