MAUDE Adverse Event Report: TRACOE MEDICAL GMBH TRACOE TWIST TRACHEOSTOMY CANNULA; TRACOE TWIST TRACHEOSTOMY CANNULA WITH CUFF AND SUCTION LINE

Model Number	REF 302-07
Medical Device Problem Codes	Gas/Air Leak (2946); Failure to Deflate (4060)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The cannulas don't last a week, (6-7 days) they leak, they have to be inflated several times, and when they want to deflate them completely, they can't suck out the air, they take them out with a partially inflated cuff.They noticed that the bottom of the cuff turns in towards the bottom of the cannula, meaning that the cuff fixation of the patient side was partly detached.They realized this because the saturation had dropped, and as a last resort they tried to change the cannula no health effect on the patient reported.
Additional Manufacturer Narrative
According to the complaint description, the provided photos and returned samples, the tracheostomy tube cuff slipped down the shaft of the tube and partially blocked the cannula lumen during use.Verification of the defect based on the samples which showed that the cuff detached at the proximal gluing side and shifted toward the lower end gluing side.Tracing the batch number showed no deviations or problems in production or in other applications.Based on the user communication the cuff pressure was not controlled with a cpm (cuff pressure monitor) but only inflated with a syring without measuring and controling the cuff pressure.The cuff was inflated several times because it was assumed that the cuff leaks.This may lead to an repeated overinflation of the cuff which might support the increasing detachment of the cuff bonding.This effect was successfully simulated in experiments however, incomplete or only partial adhesion of the cuff may also have contributed to the detachment.Therefore, we must assume that this error pattern is due to multiple factors.

• Brand Name: TRACOE TWIST TRACHEOSTOMY CANNULA
• Common Device Name: TRACOE TWIST TRACHEOSTOMY CANNULA WITH CUFF AND SUCTION LINE
• 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: 24962197
• Report Number: 8010485-2026-70353
• Device Sequence Number: 10463871
• Product Code: JOH
• UDI-Device Identifier: 04035324033614
• UDI-Public: 4035324033614
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace,Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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 302-07
• Device Catalogue Number: REF 302-07
• Device Lot Number: 1100056355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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: Required Intervention
• Patient Sex: Unknown