MAUDE Adverse Event Report: TRACOE MEDICAL GMBH TRACOE VARIO TRACHEOSTOMY TUBE

Model Number	REF 460-08-P
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the complaint description, a white plastic part came loose when the insertion aid was removed, after inserting the tracheal tube.During the tracheotomy described, we used the pre-assembled insertion aid.The detached tip had to be removed from the patient via bronchoscopy.As no photo/sample was available to date, a theoretical investigation was conducted.Based on the complaint description, the issue could be assigned to the known failure pattern concerning the silicone sleeve separation.Investigation within capa-000444 is ongoing.Most likely a possible cause is associated with the bonding process.However, no batch-related issue could be identified, and - according to the capa risk assessment and trend evaluation; is still within an acceptable level according to the product risk assessment.Currently it is difficult to definitively conclude what caused the problem in this case, as the affected product was not available for examination to date.
Event or Problem Description
During the tracheotomy described, we used the pre-assembled insertion aid.After inserting the tracheal tube, a white plastic part came loose when the insertion aid was removed.No photographic documentation is available.The patient suffered no harm.

• Brand Name: TRACOE VARIO TRACHEOSTOMY TUBE
• Common Device Name: TRACOE VARIO TRACHEOSTOMY TUBE
• 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: 24468789
• Report Number: 8010485-2026-65313
• Device Sequence Number: 9615776
• Product Code: JOH
• UDI-Device Identifier: 04035324017799
• UDI-Public: 4035324017799
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203362
• 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: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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 460-08-P
• Device Catalogue Number: REF 460-08-P
• Device Lot Number: 1100047160
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2024
• 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 Sex: Unknown