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

Model Number	REF 311-08
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of this incidents needs further details from the user/customer.These are: - were a cuff check performed with both tracheostomy tubes before use? - not answered - which method was used to measure the cuff pressure? not answered - what was the measured pressure when the leakage was detected? not answered furthermore, the affected tubes needs to be returned to tracoe for investigation.Without the investigation of both tubes a root cause analysis is not possible and very limited.The tube was returned to tracoe and examined on 30.04.2025: a small hole was discovered in the cuff.The cause of this hole cannot be clearly clarified, as the results of the a priori cuff test are missing.All cuffs of the tracheostomy cannulas are subjected to a 100% test at tracoe as part of the quality inspection during production.Leaking products are discarded.However, the leaking problem was directly detected after the insertion of the tube.It is therefore unclear if the cuff was damaged during insertion, preparation or before use.It can be assumed that sharp-edged structures in the area of the cuff have led to the leakage right after the insertion of the tube.Nevertheless, the cause cannot be conclusively determined due to the missing goods.
Event or Problem Description
1) what went wrong with the device: it was reported that the cuff of a tracoe twist plus deflated immediately after the insertion of the cannula.It was not reported of the cuff was tested before use as it is described in the ifu.2) description of health effects: it was reported that some bleeding occured.The patient went for the tube change to the hospital and left the hospital afterwards.

• Brand Name: TRACOE TWIST PLUS TRACHEOSTOMY CANNULA
• Common Device Name: TRACOE TWIST PLUS TRACHEOSTOMY CANNULA WITH CUFF
• 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: 21933224
• Report Number: 8010485-2025-00020
• Device Sequence Number: 8714708
• Product Code: JOH
• UDI-Device Identifier: 04035324017959
• UDI-Public: 04035324017959
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K961449
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

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 311-08
• Device Catalogue Number: REF 311-08
• Device Lot Number: 1100037850
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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: Other
• Patient Sex: Unknown