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

Model Number	100/179/055
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
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 involvement.
Additional Manufacturer Narrative
Other text: nine photos were provided for evaluation.Photo 3, photo 6, and photo 9 showed cuts on the tip tubes.Three (3) samples were returned for evaluation.The returned samples were visually inspected; cuts on the tip tubes were found on the 3 returned samples.Functional testing was performed; leakage was detected in all three samples.The complaint was confirmed.The cuff won't inflate failure mode was confirmed.The most likely root cause is that the bevel tube formation operation was not followed.An awareness notification was made to the production personnel.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: PORTEX IVORY PVC, NASAL, SOFT SEAL CUFF TRACHEAL
• 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; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 14515860
• Report Number: 3012307300-2022-09707
• Device Sequence Number: 6531220
• Product Code: BTR
• UDI-Device Identifier: 15019315022098
• UDI-Public: 15019315022098
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/19/2022

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 Expiration Date: 08/01/2026
• Device Model Number: 100/179/055
• Device Catalogue Number: 100/179/055
• Device Lot Number: 4169638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• 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: 04/28/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• 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