MAUDE Adverse Event Report: TRACOE MEDICAL GMBH TRACOE TWIST SPARE INNER CANNULAS

Model Number	REF 501-08-X
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026 it was reported that when attempting to change tracheostomy inner cannula in one of the itu patients, it was noted that the tube was unable to be fully inserted.Checked with another inner cannula from the same batch number (1100048974) and same issue identified.Tried with a new tracheostomy tube and similar happened - was able to inserted and removed but with significant resistance and imposing a real risk displacement of patient artificial airway if used.No health effect on the patient reported.
Additional Manufacturer Narrative
According to the complaint description it was noted that the the tube was unable to be fully inserted, when attempting to change tracheostomy inner cannula in one of the itu patients.Checked with another inner cannula from the same batch number (1100048974) and same issue identified.There are no sample available for defect verification, but requested.Therefore, theorethical investigation was conducted with available information.Tracing of the lot number related to the complaint revealed no further recurrences of the same issue within the batch; the incoming good inspection and the production data are inconspicious.Rca-> cause cannot be determined as sample are not available.

• Brand Name: TRACOE TWIST SPARE INNER CANNULAS
• Common Device Name: TRACOE TWIST SPARE INNER CANNULAS
• 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: 24398361
• Report Number: 8010485-2026-65077
• Device Sequence Number: 8168665
• Product Code: JOH
• UDI-Device Identifier: 04035324017904
• UDI-Public: 4035324017904
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K961449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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 501-08-X
• Device Catalogue Number: REF 501-08-X
• Device Lot Number: 1100048974
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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
• Patient Sex: Unknown