MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX SOFT SEAL CUFF TRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/199/065
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cuff was leaking after 10 minutes in 2 units of the products.The device had to be replaced.
Additional Manufacturer Narrative
One device was returned for evaluation.No defects were detected, during visual inspection.Leakage was detected during functional testing.The complaint was confirmed.The leak was found in the joint between the pilot balloon and valve.The root cause was due to a lack of solvent in the joint between the pilot balloon and valve.Notification was made to production personnel by quality engineer on 23/may/2022.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record review.
Event or Problem Description
This was an adverse event.

• Brand Name: PORTEX SOFT SEAL CUFF TRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; bangna-trad road; minneapolis, MN 55442
• MDR Report Key: 14090202
• Report Number: 3012307300-2022-06250
• Device Sequence Number: 4804499
• Product Code: BTR
• UDI-Device Identifier: 15019315022319
• UDI-Public: 15019315022319
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K790312
• 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
• Report Date (Section B): 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2024
• Device Model Number: 100/199/065
• Device Catalogue Number: 100/199/065
• Device Lot Number: 3828336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/25/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian