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

Model Number	REF 373-4.0-C45
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A photo of the reported product was provided, which appeared to indicate that the tracheostomy tube size (inner diameter) was correctly labeled on the neck plate and the packaging as 4mm.However, on the pilot balloon, the tube size was labeled as 3.5 mm.The investigation of batch records and remaining stock at the distributors shows that all other products of this batch are labelled correctly.In addition, no other complaint regarding this mislabelling error has been received.There is a strong indication that this is a one-off case, caused by a mix-up of a pilot balloon in the assembly process.This process has been modified to prevent future occurence.
Event or Problem Description
Tracheostomy tube tracoe silcosoft with size 4.0 printed on the wing and package labelling, but a different size 3.5 printed on the pilot balloon.The size on the balloon is wrong.

• Brand Name: TRACOE SILCOSOFT
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): TRACOE MEDICAL GMBH; reichelsheimer strasse 1; nieder-olm, rp 55268 ; GM 55268
• MDR Report Key: 11062366
• Report Number: 3003361161-2020-00001
• Device Sequence Number: 3692070
• Product Code: JOH
• UDI-Device Identifier: 04035324031399
• UDI-Public: 04035324031399
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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 Expiration Date: 03/01/2025
• 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1