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

Model Number	REF 316-07
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
1) cuff leak was observed during use after round about 1 month of use, which is approximately the maximum duration of use of 29 days.It is reported that a priori cuff testing was done and passed.2) no health effect to the patient reported.The tracheostomy tube with the cuff problem was changed the following day.
Additional Manufacturer Narrative
A theoretical investigation was conducted, as there were no photos and no goods available.No further details have been provided.All cuffs of the tracheostomy cannulas are subjected to a 100% test as part of the quality inspection during production.Leaking products are discarded.However, after a passed a priori cuff check, the leaking problem occured during some days of use.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 line.It can be assumed that sharp-edged structures in the area of the cuff have led to the leakage during use especially as the end of the application time may have been reached or already exceeded.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: 21066112
• Report Number: 8010485-2024-00056
• Device Sequence Number: 3302371
• 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: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2025

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: 1100029073
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 01/03/2025
• 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 Age: 60 YR
• Patient Sex: Male