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

Model Number	REF 316-08-P
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
1) cuff leak was observed during use after 23 days of use.2) no health effect to the patient occured.The tracheostomy tube with the cuff problem was changed.
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.All cuffs of the tracheostomy cannulas are subjected to a 100% test as part of the quality inspection during production.Leaking product was discarded.The leaking problem occured after 23 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.Nevertheless, the cause cannot be conclusively determined due to the missing goods and further use details.

• 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: 20817955
• Report Number: 8010485-2024-00045
• Device Sequence Number: 12683394
• Product Code: JOH
• UDI-Device Identifier: 04035324019229
• UDI-Public: 4035324019229
• 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): 12/02/2024

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 316-08-P
• Device Catalogue Number: REF 316-08-P
• Device Lot Number: 1100033125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 12/02/2024
• 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 Age: 56 YR
• Patient Sex: Male