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 Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 2026-01-09 an increased risk of aspiration due to a faulty tracheostomy tube cuff was reported.The faulty tube had been inserted on (b)(6) 2025 and was found to be faulty on (b)(6) 2026.Prior to insertion, the cuff was tested, with no air leakage noted at that time.On (b)(6) 2026, staff found cuff to be deflated.The patient exhibits involuntary movements, including lifting both hands toward the chest and flexing the neck downwards, which occur daily and may have exerted pressure on the tracheostomy system.The tracheostomy tube was removed and replaced by nursing staff.No health effect on the patient.
Additional Manufacturer Narrative
According to the complaint description the cuff was faulty.After 4 hourly inner tube changes are completed and 8 hourly manometer checks are completed routinely, this issue was found by staff during a manometer check.Further information and the sample was requested but not received up to date.Therefore, a theoretical investigation was conducted.Tracing of the lot number related to the complaint revealed no recurrences of the same issue within the batch; incoming goods inspection and production data are inconspicuous.All cuffs and cuff systems of the tracoe tracheostomy cannulas undergo a 100% quality inspection during production, with any leaking or nonperforming products being discarded.Itis therefore confirmed that the product is originally in perfect condition, including a tight cuffsystem and a working cuff inflation via the inflation line.However, the cuff-system leaked during use.Therefore, it can be assumed that sharp-edged structures in the area of the cuff led to the leakage during use e.G.Sharp cartilage ridges.Nevertheless, it cannot be determined whether the cuff-check and handling at the user's side was carried out according to ifu.Therefore, the cause cannot be conclusively determined.

• 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: 24187096
• Report Number: 8010485-2026-63743
• Device Sequence Number: 8065015
• 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): 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 306-07
• Device Catalogue Number: REF 306-07
• Device Lot Number: 1100051308
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 46 YR
• Patient Sex: Male