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

Model Number	REF 303-05
Medical Device Problem Codes	Mechanical Problem (1384); Material Separation (1562)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only a photo of the defective cannula was available for examination.This showed the dismantled neck plate and the joint ring.No defects or faults were found on either the neck plate or the joint ring - the neck plate is hardly visible on the photo.It is therefore not possible to determine whether there was a material or shape defect in the joint or the neck plate.Another cause could be a strong force acting on the neck plate, which led to a strong deformation of the components and thus to the separation of the neck plate.Due to the absence of the affected sample, none of the causes can be confirmed.
Event or Problem Description
1) what went wrong: during a routine cannula change the new cannula split in two parts right after the insertion.The tube separates from the neck plate.No breaks or cracks of the material of tube and neck plate are visible.2) description of health effect: bleeding at tracheostoma probably cause by the tube change.

• Brand Name: TRACOE TWIST TRACHEOSTOMY CANNULA
• Common Device Name: TRACOE TWIST 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: 21581664
• Report Number: 8010485-2025-00009
• Device Sequence Number: 8757156
• Product Code: JOH
• UDI-Device Identifier: 04035324034116
• UDI-Public: 4035324034116
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Inspection,Replace,Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

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 303-05
• Device Catalogue Number: REF 303-05
• Device Lot Number: 1100035724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown