MAUDE Adverse Event Report: TRACOE MEDICAL GMBH TRACOE SILCOSOFT; TRACOE SILCOSOFT PL TRACHESOSTOMY TUBE

Model Number	REF 373-4.0-C48
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No foto and no product provided for investigation.There is a strong indication that the defect described as blown cuff was caused by either a wrong or to aggressive cleaning and/or sterilization procedure.The defect pattern is typical for damage during wrong processing.There is a certain degree of doubt that the ifu specifications for reprocessing were followed correctly.It is known from several clinics that the reprocessing procedures of the hospitals are not adapted completely to the specifications given in the ifu.There is a risk of product damage if other methods are used.This note is listed in the ifu of the product.We suppose that the damage was not noticed during the product inspection and the leak test of the cuff system , which are mandatory after every reprocessing procedure (described in the ifu) and that a product possibly pre-damaged by sterilisation was used.The user has been advised to observe the cleaning and sterilisation instructions in the ifu and to test the product carefully and completely before using it again after processing.
Event or Problem Description
Upon assessment of tracheostomy cuff, it was noted that the cuff was deflated although it was inflated with 2 mls of sterile water a few hours prior.The decision was made to change the tracheostomy tube.On examination after, it was noted that the cuff was blown.

• Brand Name: TRACOE SILCOSOFT
• Common Device Name: TRACOE SILCOSOFT PL TRACHESOSTOMY TUBE
• Manufacturer (Section D): TRACOE MEDICAL GMBH; reichelsheimer str. 1/3; nieder-olm, 55268 ; GM 55268
• MDR Report Key: 11676901
• Report Number: 3003361161-2021-00001
• Device Sequence Number: 2980886
• Product Code: JOH
• UDI-Device Identifier: 04035324031405
• UDI-Public: 04035324031405
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: 12/31/2025
• Device Model Number: REF 373-4.0-C48
• Device Catalogue Number: REF 373-4.0-C48
• Device Lot Number: 1000180424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 DA