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

Model Number	REF 316-10
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	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Subglottic port fell off.Tube changed.No harm to the patient reported.
Additional Manufacturer Narrative
The investigation of the affected sample was not possible because the product was not returned to tracoe.No photos of defective device was available.Based on the incident description it can be supposed that the defect described relates to the known product error of the subglottic suction line detachment.Further investigations are conducted within capa 000106/330.The cause is probably due to the bonding process of the subglottic suction line.It is possible that preparation steps before bonding were not carried out sufficiently or correctly, or that the bonding was not carried out correctly.Further root cause can be attributed to a design limitation of the component.Other causes could also be seen within the use period, e.G.The use of different cleaning or disinfection agents, humification with a humification mask, as well as strong pulls on the suction line.
Additional Manufacturer Narrative
According to the complaint description a subglottic port detachment from the tracheostomy tube was detected.No photo/sample discarded.Therefore, no defect verification possible.Nevertheless, based on the complaint description, the issue can be related to known failure pattern concerning subglottic suction line detachment with other sizes of twist plus tubes during clinical use.However, this is a single event with size 10.Tracing of the lot number related to the complaint revealed no recurrences of the same issue within the batch.There was a deviation with the ipc registered but with special release as only slight shortfall.Certain clinical conditions, such as inhalation therapy, mechanical stress, microbiological environment, may contribute to adhesive bond failure.Therefore, and as this was a single event on this size without possibility of defect verification, the cause cannot be conclusively determined.
Event or Problem Description
Subglottic port fell off.Tube changed.No harm to the patient reported.

• Brand Name: TRACOE TWIST PLUS TRACHEOSTOMY CANNULA
• Common Device Name: TRACOE TWIST PLUS 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: 24934657
• Report Number: 8010485-2026-72161
• Device Sequence Number: 16119159
• Product Code: JOH
• UDI-Device Identifier: 04035324019106
• UDI-Public: 4035324019106
• 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,Followup
• Report Date (Section B): 04/30/2026

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 316-10
• Device Catalogue Number: REF 316-10
• Device Lot Number: 1100051154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2024
• 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