MAUDE Adverse Event Report: TRACOE MEDICAL GMBH TRACOE MINI TRACHEOSTOMY CANNULA

Model Number	REF 355-3.0
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Cough (4457)
Date of Event	08/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following investigation have been carried out: photo: neck plate with traces of glue in the opening where the tube should be connected to the neck plate.Bonding process was carried out.Production documents: no abnormalities in the production process of both batches mentioned by the complaint reporter.Trend analysis: no comparable complaint an defect reported within the last 5 years.Product investigation: not possible because affected product was not returned to tracoe.The reporter could not name the exact batch of the product concerned, therefore 2 batches sold to the medical facility were indicated.No abnormalities were found in the production of either of the batches mentioned.The described defect has not been reported in the last 5 years.We therefore assume that this is a rare, isolated case.The cannula was used for 10 days without any problems.It was not reported what exactly led to the separation of the cannula tube.
Event or Problem Description
Tracoe mini tracheostomy cannula broke between tube and neck plate while the patient was napping.The tube remain in the trachea and became a foreign body.The tracheostomy cannula was in use only for one week.Tube of the cannula was removed in hospital.

• Brand Name: TRACOE MINI TRACHEOSTOMY CANNULA
• Common Device Name: TRACHEOSTOMY CANNULA
• 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: 20244227
• Report Number: 8010485-2024-00031
• Device Sequence Number: 12585685
• Product Code: JOH
• UDI-Device Identifier: 04035324011971
• UDI-Public: 04035324011971
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

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: Health Professional
• Device Model Number: REF 355-3.0
• Device Catalogue Number: REF 355-3.0
• Device Lot Number: 1100017914, 1100021154
• 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: 08/20/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Sex: Male