MAUDE Adverse Event Report: TRACOE MEDICAL GMBH TRACOE TWIST PLUS TRACHEOSTOMY CANNULA

Model Number	REF 312-07
Medical Device Problem Code	Gas/Air Leak (2946)
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
1) a cuff leak of the tracheostomy cannula was observed during use afer 26 to 27 days of use, by an allowed usage time of 29 days.2) no health effect to the patient occured.The tracheostomy tube with the cuff problem was changed or an early decannulation done.
Additional Manufacturer Narrative
A theoretical investigation was conducted, as there were no photos and no goods available.All cuffs of the tracheostomy tubes are subjected to a 100% test as part of the quality inspection during production.Leaking products are discarded.However, the problem occured at the last days of the allowed usage time of 29 days at day 26/27.It is therefore confirmed that the product was originally in perfect condition, including a tight cuff-system and a working cuff inflation via the inflation it can be assumed that sharp-edged structures in the area of the cuff have led to the leakage during use.Nevertheless, the cause cannot be conclusively determined due to the missing goods.

• Brand Name: TRACOE TWIST PLUS TRACHEOSTOMY CANNULA
• Common Device Name: TRACOE TWIST PLUS 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: 20479302
• Report Number: 8010485-2024-00034
• Device Sequence Number: 15507320
• Product Code: JOH
• UDI-Device Identifier: 04035324017980
• UDI-Public: 4035324017980
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: REF 312-07
• Device Catalogue Number: REF 312-07
• Device Lot Number: 1100027659
• 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: 09/19/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown