MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TRACHEAL TUBE IVORY NASAL SOFT SEAL CUFF 5; 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	08/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that a customer tried to put air in the cuff during the pre-use check, but the cuff would not inflate and leakage of air was observed.No patient injury was reported.
Additional Manufacturer Narrative
H10: device evaluation: three photos and one cuff sample were received in used condition without the original packaging.Visual examination of the photos indicated damage to the tube tip.Visual inspection of the returned sample at a distance of 12 to 16 inches un normal condition of illumination revealed damage on the tube tip.Additionally, a syringe was connected to the pilot balloon to allow air through the tube to confirm the place of the leak.An air leak was confirmed in the tube tip.The customer complaint was confirmed.Based on the analysis conducted with the sample provided, the root cause would be attributed to damage during the manufacturing process.A customer complaint notification was made to production personnel to explain the importance of adherence to following the procedure.A device history record (dhr) review was conduction, there were no issues, nonconformances reported during the manufacture of this lot.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX TRACHEAL TUBE IVORY NASAL SOFT SEAL CUFF 5
• 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: 15391893
• Report Number: 3012307300-2022-18255
• Device Sequence Number: 4947029
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 06/23/2023
• 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