MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX MINI-TRACH II KIT; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION

Model Number	198-35L
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the use of the product, the customer noticed the tube's lumen was curved in an s shape.No patient injury was reported.
Additional Manufacturer Narrative
One (1) photo was received for evaluation.A bent tube was observed in the photo.Based on the analysis conducted in the sample provided, the failure mode reported was confirmed.The occurrence of this failure condition could be caused by: method not followed (mandrel not inserted at the right distance) or method not followed (the tube was not checked width the forming fixtures).Awareness notification was performed on 08-oct-2021 to personnel to notify the complaint reported.Additionally, a quality alert qalert-21156 was generated on 21-oct-2021 to personnel to reinforce the proper use of the forming fixture.No lot number provided for dhr.

• Brand Name: PORTEX MINI-TRACH II KIT
• 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; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 13502007
• Report Number: 3012307300-2022-03088
• Device Sequence Number: 3952548
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2022

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown