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

Model Number	4CN65H
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Airway Obstruction (1699); Cardiac Arrest (1762); Dyspnea (1816); Hypoventilation (1916); Loss of consciousness (2418); Respiratory Failure (2484)
Date of Event	05/29/2023
Type of Reportable Event	Death
Event or Problem Description
According to the reporter, the patient was a home care patient, that was using an adult tracheostomy tube, and was connected to a ventilator.The reporter stated the patient ¿was unable to breathe¿ as air was unable to get in past the tracheostomy tube.The ventilator was checked and showed normal operation.It was additionally reported that emergency response (911) was called, and upon arrival; medication, heart pump and manual ventilation via ambu bag were applied by the medical responders with negative results.The patient was transported to the hospital but died.The reporter stated the medical examiner¿s report attributed the death to cardiac arrest that resulted from mucous in the trach which prevented air from getting into the patient¿s system.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
According to the reporter, the patient was a home care patient that was using an adult tracheostomy tube and was connected to ventilators.The reporter stated the patient ¿was unable to breathe¿ as air was unable to get in past the tracheostomy tube and the patient lost consciousness.The ventilator was checked and showed normal operation.It was additionally reported that emergency response (911) was called, and upon arrival; medication, heart pump and manual ventilation via ambu bag were applied by the medical responders with negative results.The patient was transported to the hospital.Resuscitation efforts by first responders and hospital personnel were unsuccessful.The patient died.The reporter stated the medical examiner¿s report attributed the death to cardiac arrest that resulted from mucous in the trach which prevented air from getting into the patient¿s system.
Additional Manufacturer Narrative
H9: z-1357-2023 additional information: a1, a2, a3, b2, b3, b5, b7, d3, d4, e, g1, g2, g3, h4 and h6.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 32590 ; MX 32590
• Manufacturer (Section G): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32590 ; MX 32590
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 17538030
• Report Number: 2936999-2023-00649
• Device Sequence Number: 15088739
• Product Code: JOH
• UDI-Device Identifier: 20884521176307
• UDI-Public: (01)20884521176307(17)270425(10)22D0799JZX(20)03
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Other,Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4CN65H
• Device Catalogue Number: 4CN65H
• Device Lot Number: 22D0799JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 08/13/2023
• Supplement Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 04/25/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2936999-03-13-2023-002-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Death
• Patient Age: 62 YR
• Patient Sex: Female