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

Model Number	REF 521-08
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the analysis cannot yet be fully completed.There are some inconsistencies in the error description that have not yet been clarified due to the lack of feedback from the customer: the specified part number ref (b)(4) does not match to the description of the cannula as a twist cannula.The ref (b)(4) number corresponds to a twist plus cannula.Reference is made to the two replacement cannulas included with the product, but the product itself is not named.Instead, the listed product is a set of replacement cannulas with 10 replacement inner cannulas.The batch number provided corresponds to a ref (b)(4) size 10, which is not mentioned in the error description.Only size 8 and 9 cannulas are mentioned and potentially affected there.Due to the discrepancies present and the missing information, a conclusive investigation and evaluation of the case is not possible.However, it should be noted that the ifu specifies that a replacement cannula should always be available so that a replacement can be made immediately if problems arise.This was not taken into account in this case.
Event or Problem Description
The nurse tried to change the inner canula.He removed the dirty inner canula and tried to inser the new one.It was impossible to introduce the new inner canula in the twist canula.He decided to use again the dirty canula.After that, he looked the inner canula with caution and he discovered that the size of the inner canula was not the good one.It was a size 9 instead of a size 8.In the package they received a canula size 8 with 2 inner canula: one size 8 and another one size 9.The oxygen saturation of the patient decrease at 40%.They should increase fi02 until the saturation went back to 100% discomfort of the patient.

• Brand Name: TRACOE TWIST PLUS TRACHEOSTOMY SPARE CANNULA
• Common Device Name: TRACOE TWIST PLUS TRACHEOSTOMY SPARE 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: 24647922
• Report Number: 8010485-2026-67703
• Device Sequence Number: 13304105
• Product Code: JOH
• UDI-Device Identifier: 04035324018208
• UDI-Public: 4035324018208
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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 521-08
• Device Catalogue Number: REF 521-08
• Device Lot Number: 1000199632
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2024
• 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
• Patient Sex: Unknown