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

Model Number	REF 450-08-P
Medical Device Problem Codes	Use of Device Problem (1670); Unintended Movement (3026)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
1) what went wrong with the device: on (b)(6) 2025 it was reported while a patient was being repositioned from a supine to a lateral position for a puncture, the tracheal cannula became twisted inside the shield despite the lock being correctly adjusted (lock symbol closed).As a result, the tracheal cannula was no longer positioned correctly in the trachea and initially leaked.The patient then had to be reintubated as an emergency measure because ventilation was impossible.A bronchoscopy showed that the cannula was lying with the opening against the mucous membrane of the trachea and was therefore misplaced.2) description of health effects: no harm was caused to the patient.Short-term undersupply of breathing air.
Additional Manufacturer Narrative
According to the complaint description the tracheal cannula became twisted inside the neck plate despite the lock being correctly adjusted (lock symbol closed), while a patient was being repositioned.It was stated that the neck flange was fixated with a neck strap & stitches.As no sample is available for investigation a theoretical investigation was conducted.As the lot is unknown, a review of batch & production data is not possible.The received photo is not sufficient for defect verification.The sliding neck plate is secured to the cannula tube by a locking mechanism.To move the nekc plate, the orange lever must be released and then closed again after moving.To ensure that the cannula is always correctly oriented, attention should therefore be paid to the position of the scale, as described in the ifu: "for correct orientation of the tube and adjustable neck flange, it is essential, that the scale on the tube faces upwards (cranial) and the distal end of the tube is oriented caudal.The information engraved on the neck flange must be readable (tracoe logo towards patient's chin" and "the tube must not be moved or shifted once it is in position)".The ifu also states that the correct position and function of the cannula must be checked, see "ensure the correct placement of the tube by regularly checking of the tube position and reduce the risk of dislocation.

• 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: 24187582
• Report Number: 8010485-2026-63112
• Device Sequence Number: 8065029
• Product Code: JOH
• UDI-Device Identifier: 04035324017027
• UDI-Public: 4035324017027
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/27/2026

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 450-08-P
• Device Catalogue Number: REF 450-08-P
• Device Lot Number: N.A.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 01/27/2026
• 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