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

Model Number	REF 316-07
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Suction line detached from tracheostomy cannula.
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 000106.The batch number shows that the cannula was produced before the implementation of the capa actions.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, as well as strong pulls on the suction line.Probably this was not possible with the patient.

• Brand Name: TRACOE TWIST PLUS TRACHEOSTOMY CANNULA
• Common Device Name: TRACOE TWIST TRACHEOSTOMY CANNULA WITH CUFF AND SUCTION LINE
• Manufacturer (Section D): TRACOE MEDICAL GMBH; reichelsheimer str. 1/3; nieder-olm, 55268 ; GM 55268
• MDR Report Key: 20425519
• Report Number: 8010485-2024-00033
• Device Sequence Number: 15579966
• Product Code: JOH
• UDI-Device Identifier: 04035324019076
• UDI-Public: 4035324019076
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2024
• Report Date (Section F): 09/19/2024

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: Lay User/Patient
• Device Model Number: REF 316-07
• Device Catalogue Number: REF 316-07
• Device Lot Number: 1100036921
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 WK
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male