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

Model Number	6FEN
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction

• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 25804194
• Report Number: 9681384-2026-00727
• Device Sequence Number: 5842250
• Product Code: JOH
• UDI-Device Identifier: 60884522007028
• UDI-Public: (01)60884522007028(17)300820(10)25H0869JZX
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K962173
• 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
• Type of Report: Initial
• Report Date (Section B): 07/13/2026

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: 6FEN
• Device Catalogue Number: 6FEN
• Device Lot Number: 25H0869JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 07/13/2026
• Date Device Manufactured: 08/20/2025
• 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