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

Model Number	REF 450-07-P
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the complaint description, the white silicone sleeve detached from the guiding catheter when being pulled out and remained inside the cannula, requiring the cannula to be changed.The examination of the affected product could not be carried out as the product was not received due to contamination.However, the provided photo showed the silicone sleeve separated from the guiding catheter.Tracing lot: 1100031252 (manufactured on 14.12.2023) showed no recurrence of this issue within the lot, suggesting that this may be an isolated incident.No batch-related issue could be identified.Based on the review of production documents and records of the incoming goods inspection of the affected parts, including tensile tests of the bonding between the silicone sleeve and guiding catheter, no particularities or deviations were found.This issue is currently being addressed within the initiated capa: 000444 (corrective and preventive action).The investigation has not yet been completed, but it cannot be ruled out that a possible cause is associated with the bonding process.The bonding process is validated and controlled with in-process control measures.Batches that do not fulfill the acceptance criteria, including tensile tests, are discarded.However, it cannot be ruled out that in very rare individual cases the bonding or preparation steps before bonding were not carried out correctly.Nevertheless, it is difficult to definitively conclude what caused the problem in this case, as the affected product cannot be examined.
Event or Problem Description
1) what went wrong with the device: during the insertion of the cannula (vario -p tube), the silicone sleeve, which was supposed to be removed after the cannula was inserted, was not removed.When the doctor noticed this, he removed the cannula along with the silicone part, and inserted a new cannula of the same type into the patient.In parallel with this operation, manual ventilation was performed since an alert was received that the patient was not connected to the mechanical ventilator, but after replacing the cannula, as described above, the ventilator worked properly, and the patient was ventilated.2) description of health effects: no harm was caused to the patient.It should be noted that this is the second similar event which occured in the hospital.

• 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: 23836610
• Report Number: 8010485-2025-60701
• Device Sequence Number: 5080615
• Product Code: JOH
• UDI-Device Identifier: 04035324017003
• UDI-Public: 4035324017003
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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 450-07-P
• Device Catalogue Number: REF 450-07-P
• Device Lot Number: 1100031252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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