MAUDE Adverse Event Report: TRACOE MEDICAL GMBH TRACOE EXTENSION PIECE; EXTENSION TUBE

Model Number	REF 356
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	09/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following investigation have been carried out: photo: the quality of the photos are not high enough to use them for the investigation.Production documents: no abnormalities in the production process of the affected batch.Trend analysis: no comparable complaint and defect reported within the last year.We therefore assume that this is a rare, isolated case.Product investigation: not possible because affected product was not returned to tracoe.Usage: the application time of the extension piece was no reported.
Event or Problem Description
1) what went wrong: the 15 mm connector of the extension piece was disconnected from the extension tube and was still attached to the tracheostomy tube.Therefor the connection was interrupted and the ventilator alarmed.The tube was changed afterwards, instead of removing the 15 mm connector from the tracheostomy tube.2) health effect: short term desaturation, no further health effect reported.

• Brand Name: TRACOE EXTENSION PIECE
• Common Device Name: EXTENSION TUBE
• 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: 21302425
• Report Number: 8010485-2025-00002
• Device Sequence Number: 18373294
• Product Code: BZA
• UDI-Device Identifier: 04035324019069
• UDI-Public: 04035324019069
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: D118287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/04/2025

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 356
• Device Catalogue Number: REF 356
• Device Lot Number: 1100036220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Prefer Not To Disclose