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

Model Number	REF 470-08
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: examination of product(s) returned - no product returned yet qc and production documentation: inspection of the incoming goods of the related batch was without any deviation.Supplier complaint submitted to the manufacturer of the obturator.Manufacturer identifies affected production batches of the obturator.The root cause analysis has been carried out as part of capa: 000315.Possible causes were identified in the application or in the material and manufacturing of the obturator.Incorrect use of the obturator could be ruled out as the user reported no manipulation or peculiarities in the application.It can therefore be assumed that the tip of the obturator was not pre-damaged and that the tensile forces applied by the user did not exceed a normal range.The manufacturer's root cause analysis indicated that inappropriate injection temperature during processing could be causing the fault.The following measures were therefore initiated by the supplier: refreshing training of the moulding machine operators.And a modification of the mould sockets to increase the integrity of the tip.The mentioned lot number was manufactured before implementation and completion of the capa: 000315.Initiation of capa and timely termination.Capa status: completed.Initiation of fsca 2025-07 with safety notification, bfarm ref.(b)(4): fsca 2025-07 will start on 11.08.2025, the termination is planned for end of september 2025.
Event or Problem Description
1) what went wrong with the device: an obturator is installed in the lumen of the tracheostomy cannula, which makes it easier to insert the cannula in the trache and to reduce the caliper gap between the outer diameter of the cannula and a guide.The obturator is pulled out after the cannula has been inserted into the trachea.When pulling it out, the tip of the obturator broke off and got stuck in the lumen of the cannula.This separation was discovered immediately after insertion and after it was detected that ventilation of the patient deteriorated.An other cannula was re-inserted without any problem and ventilation continued.2) description of health effects: no harm or desaturation of the patient reported.

• Brand Name: TRACOE VARIO 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: 22642467
• Report Number: 8010485-2025-00035
• Device Sequence Number: 12931949
• Product Code: JOH
• UDI-Device Identifier: 04035324013029
• UDI-Public: 4035324013029
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K203362
• 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 Health Care Professional
• Remedial Action: Notification,Replace,Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

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 470-08
• Device Catalogue Number: REF 470-08
• Device Lot Number: 1100039718
• 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: 07/02/2025
• Initial Report FDA Received Date: 07/29/2025
• 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: 56 YR
• Patient Sex: Male