MAUDE Adverse Event Report: TRACOE MEDICAL GMBH TRACOE COMFORT TRACHEOSTOMY CANNULA; TRACOE COMFORT TRACHEOSTOMY CANNULA WITH 15 MM CONNECTOR

Model Number	REF 105-06-1
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The flange had detached from the outer tube of the tracoe comfort tube, allowing the tube to migrate into the trachea and lodge in the bronchus.Under intravenous sedation and local anaesthesia, a size 7.5 tracheostomy tube was temporarily inserted to permit passage of the bronchoscope, and the displaced segment was retrieved using a grasping instrument.The airway was restored with a functioning tube, and the patient was discharged the same day in stable condition.
Additional Manufacturer Narrative
According to the complaint description, the tracheostomy tube was fitted as per usual; however, the flange came loose from the tube, allowing the tube to enter the trachea and lodge in the bronchus.Tracing of the lot number showed no recurrence of this issue within the batch.A review of the production data indicated no deviations or anomalies during production.The defect and lot could be verified from the received photos.The cannula was used for almost one month, and it was stated that it was cleaned once or twice a day using tracoe solution.Nevertheless, the partly removed labelling at the neck plate implies harsher cleaning, which might have contributed to the defect.However, it cannot be clearly determined whether the cannula was treated and cleaned according to ifu.It is also not known whether strong forces acted on the cannula, in particular on the flange.Therefore, it is not possible to conclusively determine the cause.

• Brand Name: TRACOE COMFORT TRACHEOSTOMY CANNULA
• Common Device Name: TRACOE COMFORT TRACHEOSTOMY CANNULA WITH 15 MM CONNECTOR
• Manufacturer (Section D): TRACOE MEDICAL GMBH; reichelsheimer str. 1/3; nieder-olm, 55268 ; GM 55268
• Manufacturer (Section G): TRACOE MEDICAL GMBH; reichelsheimer str. 1/3; nieder-olm, 55268 ; GM 55268
• Manufacturer Contact: margarete halle ; reichelsheimer str. 1/3; nieder-olm, 55268 ; GM 55268
• MDR Report Key: 22951225
• Report Number: 8010485-2025-50078
• Device Sequence Number: 9893990
• Product Code: JOH
• UDI-Device Identifier: 04035324014514
• UDI-Public: 4035324014514
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K781729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Other,Replace
• Type of Report: Initial
• Report Date (Section B): 08/02/2025

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: REF 105-06-1
• Device Catalogue Number: REF 105-06-1
• Device Lot Number: 1100032602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male