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

Model Number	9UN90R
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Airway Obstruction (1699); Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: 8un85r 8.5mm adt flex trach cufflessx1 (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.
Event or Problem Description
According to the reporter, during use, the size in the box of the first device was incorrect.The patient used a caliper to check the size and found that the sizes listed on the box were incorrect.The patient mentioned that it was much smaller than the previous version, and the inner and outer diameters were not the same.The patient airway was restricted and noisy.The patient went up to a 9-mm tube, which was closer to the size of the first device, but still felt more narrowed, which caused added noise and volume restriction, and preferred to have the old style back.

• 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: 19607292
• Report Number: 8020889-2024-00103
• Device Sequence Number: 17726057
• Product Code: JOH
• UDI-Device Identifier: 10884521205536
• UDI-Public: 10884521205536
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2024

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: 9UN90R
• Device Catalogue Number: 9UN90R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 06/25/2024
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown