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

Model Number	REF 316-07
Medical Device Problem Codes	Separation Failure (2547); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the affected sample was not possible because the product was not returned to tracoe.Based on the incident description it can be supposed that the defect described relates to the known product error of the subglottic suction line detachment.Further investigations are conducted within capa: (b)(4).The cause is probably due to the bonding process of the subglottic suction line.It is possible that preparation steps before bonding were not carried out sufficiently or correctly, or that the bonding was not carried out correctly.Other causes could also be seen within the use period, e.G.The use of different cleaning or disinfection agents, humification with a humification mask, as well as strong pulls on the suction line.
Event or Problem Description
Subglottic suction line detached from tracheostomy cannula during treatment.

• Brand Name: TRACOE TWIST PLUS TRACHEOSTOMY CANNULA
• Common Device Name: TRACOE TWIST PLUS 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: 22094874
• Report Number: 8010485-2025-00021
• Device Sequence Number: 15180106
• Product Code: JOH
• UDI-Device Identifier: 04035324019076
• UDI-Public: 4035324019076
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

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 316-07
• Device Catalogue Number: REF 316-07
• Device Lot Number: 1100037853
• 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: 05/13/2025
• Initial Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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