MAUDE Adverse Event Report: TRACOE MEDICAL GMBH TRACOE SILCOSOFT; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	REF 373-4.0-C45
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Tracheostomy tube with one size printed on wing and a different size printed on balloon.
Event or Problem Description
Tracheostomy tube with one size printed on wing and a different size printed on balloon.

• Brand Name: TRACOE SILCOSOFT
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): TRACOE MEDICAL GMBH; reichelsheimer str. 1/3; nieder-olm rheinland-pfalz D-552 68; DE D-55268
• MDR Report Key: 10756919
• Report Number: 10756919
• Device Sequence Number: 11722701
• Product Code: JOH
• UDI-Device Identifier: 04035324031399
• UDI-Public: (01)04035324031399
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020
• Report Date (Section F): 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: REF 373-4.0-C45
• Device Catalogue Number: REF 373-4.0-C45
• Device Lot Number: 1000166737
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/12/2020