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

Model Number	REF 521-07
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the complaint description the hcp was not able to reach the sputum, due to a piece of plastic inside the canula when he wanted to insert a suction tube into the canula.The defect was verified at the received samples which shows an inner plastic piece in the inner cannula still sticking at one point to the inner wall, which reduces the lumen.There was no lot received from the complainant.However, they have purchased item 521-07-x in (b)(6) 2025, with lot 1100043592.Tracing of the lot number related to the complaint revealed no recurrences of the same issue within the batch.However, this is a known but very rare injection molding defect caused by two mold parts not closing completely during the injection molding process.This creates a layer of plastic occluding partly the lumen of the inner canula.The product was produced in december 2024.The respective inner cannula is derived from old tools/ injection molds which are not in use any more at the supplier.This makes a reoccurrence of the described defect impossible.
Event or Problem Description
When the hcp did a regular change of the inner canula, due to a cleaning routine, he grabbed a new inner canula.He inserted it into the patient.After a while the patient started coughing and had a bit of sputum.When the hcp wanted to insert a suction tube into the canula, he was not able to reach the sputum due to a piece of plastic inside the inner canula.

• 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: 25300208
• Report Number: 8010485-2026-73054
• Device Sequence Number: 18465087
• Product Code: JOH
• UDI-Device Identifier: 04035324018192
• UDI-Public: 4035324018192
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 04/29/2026

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 521-07
• Device Catalogue Number: REF 521-07
• Device Lot Number: N.A.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown