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

Model Number	REF 301-06
Medical Device Problem Codes	Use of Device Problem (1670); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Oxygen Saturation (2477); Respiratory Insufficiency (4462)
Date of Event	04/24/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient was discharged from the hospital with a supply of ward stock tracheostomy tubes.Unfortunately, a cuffed size 7 tube was sent home when the patient required an uncuffed size 7 tube.When the patient required an unexpected tracheostomy tube change, the nurse opened the cuffed size 7 tube and realized a smaller size cuffed tube was needed.A size 6 tracheostomy tube was the only one available.The size 6 did not sit comfortably and was thought to cause over granulation of surrounding tissue and on next change the stoma started to bleed, and the tube was not able to be reinserted.This necessitated an urgent transfer to a hospital.During ambulance transport, the patient suffered a respiratory arrest, and following stabilization in the emergency department, the patient was transferred to critical care.Despite these efforts, it was determined that the patient had likely sustained a severe hypoxic brain injury and passed away afterwards.Response from hospital on (b)(6) 2026: thank you for responding- i need to clarify- this is not an issue with the faulty tube.The patient was knowingly given the incorrect tube as that was all that was available at the time in an urgent situation.The concern is that the packaging of the tubes are all very similar, and the sizing on the packaging is not very clear.This contributed to the wrong tubes being sent home with the patient.Please note that this was initially identified by the reporter as a shiley tracheostomy (medtronic product), but following medtronic's review of the device incident it was identified by the reporter that they had been mistaken, and that the tube was actually an tracoe product.
Additional Manufacturer Narrative
From the event description it is not clear which defect was assigned to the tracoe product with ref 301-06 mentioned for this severe incident.However, the hospital clarified on (b)(6) 2026 that "i need to clarify - this is not an issue with the faulty tube.The patient was knowingly given the incorrect tube as that was all that was available at the time in an urgent situation.The concern is that the packaging of the tubes are all very similar, and the sizing on the packaging is not very clear." base on this e-mail it is confirmed that the death of the patient was not related to the used tracoe products or any product defect.It is named as a customer notice and recommendation to optimize the layout of the outer package, see below.We would like to clarify that the outer packaging of tracoe twist tracheostomy tubes clearly displays all relevant product features such as cuff, fenestration, and subglottic suction on the top of the outer packaging (cardboard box).In addition, a gs1 label is applied to the side of the packaging, which provides detailed information on the tube's dimensions, including size, inner and outer diameter, tube length, cuff diameter (where applicable), and bending angle.The same gs1 label is also affixed to the inner packaging (sterile pouch), ensuring that all key information is visible both before and after opening the outer box.Furthermore, the tube size is permanently and clearly marked on the tube's neck flange, alongside other essential dimensions (diameters and length).For cuffed tubes, the size is also indicated on the pilot balloon for additional clarity.Therefore, the cause is currently considered as use error and therefore outside of manufacturer's control.

• 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: 24696695
• Report Number: 8010485-2026-67967
• Device Sequence Number: 16062157
• Product Code: JOH
• UDI-Device Identifier: 04035324032815
• UDI-Public: 4035324032815
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: REF 301-06
• Device Catalogue Number: REF 301-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/26/2026
• 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: Death
• Patient Sex: Unknown