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

Model Number	REF 105-07-1D
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A theoretical investigation was conducted, as there were no photos and no goods available.No further details of the incident were communicated by the reporter.The separation problem occured after a not reported number of days of use.It is therefore confirmed that the product was originally in perfect condition.It can be assumed that any influence during use (cleaning, forces, storage) might lead to the separation.Nevertheless, the causecannot be conclusively determined due to the missing goods and further use details.
Event or Problem Description
The neck plate separates from the canula and the cannula ended up in the bronchus.No health effect of the patient described by the reporter.

• Brand Name: TRACOE COMFORT TRACHEOSTOMY CANNULA
• Common Device Name: TRACOE COMFORT 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: 20794652
• Report Number: 8010485-2024-00044
• Device Sequence Number: 12495858
• Product Code: BTO
• UDI-Device Identifier: 04035324010820
• UDI-Public: 4035324010820
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K781729
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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
• Device Model Number: REF 105-07-1D
• Device Catalogue Number: REF 105-07-1D
• Device Lot Number: 1100029417
• 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: 11/04/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown