MAUDE Adverse Event Report: TRACOE MEDICAL GMBH TRACOE MINI TRACHEOSTOMY TUBE; TRACOE VARIO TRACHEOSTOMY TUBE

Model Number	REF 350-4.0
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Insufficient Information (4580)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
1) what went wrong with the device: according to the complaint description and 1 picture the tube/distal segment of the tracheostomy mini cannula detached during use from the neck flange and ended up in the trachea of the patient.The cannula was in use for about 40 days with an allowed use time of 29 days and was meanwhile disinfected with chlorhexidine.This disinfectant might have an effect on the bonding of neck plate to the tube, which cannot be confirmed.2) description of health effects: tube needs to be removed from the airway (bronchoscopic).No further harm of the patient reported.
Additional Manufacturer Narrative
Investigation: according to the complaint description the tube/distal segment of the tracheostomy mini cannula detached during use from the neck flange and ended up in the trachea of the patient.The defect could be verified on basis of the received photos of the detached tube part of the cannula.Tracing of the received lot number revealed no recurrences of the same issue within the batch; the production data is inconspicuous.There is a 100% inspection of connection of neck flange and tube after bonding.However, the cannula was in use for about 40 days and was meanwhile disinfection with chlorhexidine which might have affected the bonding of neck plate to the tube.There is a warning in the ifu that "under no circumstances disinfectants may be used that release chlorine".It is also not known whether further handling or strong forces acted on the cannula, and on the neck flange which might have attributed to the defect.Therefore, it is not possible to conclusively determine the cause, especially as no defective goods are available to date and the flange part of the cannula cannot be seen on the photos.However, given the evidence and circumstances, and as this is a rare defect the failure appears to be probably the result of the handling/cleaning rather than a product defect.

• Brand Name: TRACOE MINI TRACHEOSTOMY TUBE
• Common Device Name: TRACOE VARIO TRACHEOSTOMY TUBE
• 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: 22826744
• Report Number: 8010485-2025-00032
• Device Sequence Number: 13119450
• Product Code: BTO
• UDI-Device Identifier: 04035324011957
• UDI-Public: 4035324011957
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K893866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Replace,Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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 350-4.0
• Device Catalogue Number: REF 350-4.0
• Device Lot Number: 1100031321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2024
• 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: 6 MO
• Patient Sex: Male