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

Model Number	100/166/080
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Month and year of event have been provided day is unknown, no information has been provided to date.One device and two photos were returned for investigation.Testing was done where it was found that the cuff was leaking between the pilot balloon and the valve.During the manufacturing process, devices are routinely tested to ensure the manufacturing procedures are being followed.Device history review of reported lot number showed no non-conformities during the manufacturing process.The issue was thought to have happened after the device left the manufacturing site.
Event or Problem Description
It was reported that during insertion, an air leakage was observed.The device was taken out and submerged in water where it was found that there was an air leak.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

• Brand Name: SILICONISED PVC ORAL/NASAL SOFT CUFF TRACHEAL
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16587732
• Report Number: 3012307300-2023-02852
• Device Sequence Number: 5498658
• Product Code: BTR
• UDI-Device Identifier: 15019315054105
• UDI-Public: 15019315054105
• 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
• Report Date (Section B): 03/21/2023

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 Model Number: 100/166/080
• Device Catalogue Number: 100/166/080J
• Device Lot Number: 4212083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown