MAUDE Adverse Event Report: COVIDIEN AG JUAREZ (MMJ) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	9IC90
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that nursing staff noticed physical damage to a flexible disposable inner cannula, which had cracked along the distal part.Additionally, it was noted that the customer was reusing the disposable inner cannula for 24 hours up to 1 week by cleaning it when needed, despite being informed that the cannula are intended for single-use only.The issue took place in a hospital setting.The customer had been informed of the single-use nature of the cannula but chose to use them off-label according to their own protocol.The cracks were estimated to have appeared two days after the cannula were taken into use.There was no patient harm.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that the distal end was damaged (crushed) and preseted a flash.It was reported that nursing staff noticed physical damage to a flexible disposable inner cannula, which had cracked along the distal part.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: this device is classified as a disposable medical device.Frequent and routine changes of the disposable inner cannula are recommended and should be evaluated by the attending physician.Sterile only if the protective tray and cover are not open, damaged, or broken.Do not resterilize.Do not store product at temperatures above 120°f (49°c).The inner cannula should only be replaced by a shiley disposable inner cannula of the same size.Patients in the home care environment should be carefully instructed by a home health care provider in the proper use and handling of the tracheostomy tube and accessory products.The disposable inner cannula cannot be adequately resterilized by the user in order to facilitate safe reuse and is therefore intended for single patient use.Attempts to resterilize this device may result in product failure and increased risks to the patient.The disposable inner cannula is designed for single use and should not be cleaned or reused.Federal law (usa) restricts this device to sale by or on the order of a physici an.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer (Section G): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21351976
• Report Number: 9681384-2025-00137
• Device Sequence Number: 12999428
• Product Code: JOH
• UDI-Device Identifier: 10884521511927
• UDI-Public: 10884521511927
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K142296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2025

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: 9IC90
• Device Catalogue Number: 9IC90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 02/11/2025; 04/09/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 02/11/2025; 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown