MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	8CN85R
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Unintended Extubation (4564); Insufficient Information (4580)
Date of Event	05/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that at a hospital, the 8.5mm and 7.0mm tracheostomy tubes had a leaking cuff during the procedure based on the video provided.There was no reported patient outcome.
Additional Manufacturer Narrative
D10 concomitant product: 5cn70r , 5cn70r 7.0mm adt flex trach w tg cuff x1, lot# unknown.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: g3, h3 and h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.However, a video was provided.Visual inspection noted a tracheostomy tube that was leaking air from the cuff body.It was reported that the 8.5mm and 7.0mm tracheostomy tubes had a leaking cuff during the procedure based on the video provided.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: ordinarily, cuff pressure should not exceed 25 cm of h2o.Over-inflation of the cuff may cause tracheal damage and may inhibit ventilation.Consult with the attending physician.Test each tube¿s cuff, pilot balloon, and valve by inflation prior to use.If dysfunction is detected in any part of the inflation system, the tube should not be used.Cuff inflation should be checked on a regular basis, and replacement tracheostomy tubes should be kept at bedside.To ease insertion and to guard against cuff perforation from sharp edges of cartilage, taper back the cuff by deflating the cuff and gently moving it away from the distal tip of the cannula toward the neck plate as the residual air is removed by deflation.When tapering the cuff, do not use sharp instruments that would damage the cuff, such as forceps or hemostats.Avoid pulling or manipulation of the inflation line, as it is designed to conduct and hold air as part of the cuff inflation system.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: b2, b5, g3 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.
Event or Problem Description
It was reported that at a hospital, the 8.5 mm and 7.0 mm tracheostomy tubes had a leaking cuff during the procedure based on the video provided.The patient was re-intubated twice, but eventually died.
Additional Manufacturer Narrative
Additional information: d9, g3, h3 and 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 a series of small abrasions on the surface of the cuff body.When the unit was inflated, the cuff appeared distorted, and it deflated rapidly.It was reported that the 8.5 mm and 7.0 mm tracheostomy tubes had a leaking cuff during the procedure based on the video provided.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: to ease insertion and to guard against cuff perforation from sharp edges of cartilage, taper back the cuff by deflating the cuff and gently moving it away from the distal tip of the cannula toward the neck plate as the residual air is removed by deflation.When tapering the cuff, do not use sharp instruments that would damage the cuff, such as forceps or hemostats.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): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• Manufacturer (Section G): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22231039
• Report Number: 8020889-2025-00293
• Device Sequence Number: 13059444
• Product Code: JOH
• UDI-Device Identifier: 10884521205451
• UDI-Public: 10884521205451
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K150844
• 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,Followup,Followup,Followup
• Report Date (Section B): 11/24/2025

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: 8CN85R
• Device Catalogue Number: 8CN85R
• Device Lot Number: 202405168X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 06/26/2025; 09/12/2025; 11/21/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 06/30/2025; 09/16/2025; 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTES ON H11
• Patient Sex: Unknown