MAUDE Adverse Event Report: TRACOE MEDICAL GMBH TRACOE TWIST TRACHEOSTOMY CANNULA; TRACOE TWIST TRACHEOSTOMY CANNULA WITH CUFF AND SUCTION LINE

Model Number	REF 306-07
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the complaint description the 15mm connector of the inner tube came off with the catheter mount when staff attempted to remove the catheter mount whilst the inner cannula in placed.The inner cannula got stuck in the tracheostomy tube and could not be easily removed without the connector.The returned sample and the received photo shows an outer cannula where the inner tube is still sticking inside while detached from the white 15 mm connector which remained in the ventilator tube.The investigation was conducted on basis of the sample, photo and available information.Tracing of the lot 1100030273 related to the complaint revealed no recurrences of the same issue within the batch; the incoming good inspection and the production data are inconspicuous.The cause analysis and evaluation are difficult.Various causes can be suspected.On one hand, a rare error may have occurred during the production of the plug connection between the cannula tube and the 15 mm connector, which was not noticed during the subsequent review.On the other hand, strong and permanent tensile forces during ventilation may have damaged the connection, resulting in detachment of the connector.The investigation does not provide a clear cause for this rare defect, which is reported ca.2 times per year.
Event or Problem Description
On 2026-02-06 it was reported that the 15mm connector came off with the catheter mount on ventilator dependent patient.The inner cannula got stuck in the tracheostomy tube and could not be easily removed without the connector.Emergency tracheostomy change was performed.No health effect on the patient.

• Brand Name: TRACOE TWIST TRACHEOSTOMY CANNULA
• Common Device Name: TRACOE TWIST TRACHEOSTOMY CANNULA WITH CUFF AND SUCTION LINE
• 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: 24511287
• Report Number: 8010485-2026-66315
• Device Sequence Number: 21454094
• Product Code: JOH
• UDI-Device Identifier: 04035324036219
• UDI-Public: 4035324036219
• 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,Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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 306-07
• Device Catalogue Number: REF 306-07
• Device Lot Number: 1100030273
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown