MAUDE Adverse Event Report: MALLINCKRODT DAR SRL SHILEY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	SSVO
Medical Device Problem Codes	Mechanical Problem (1384); Defective Component (2292); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during use, the speaking valve could not be disconnected from the tracheostomy, it presented a collapsed appearance and no valve diaphragm movement during inspiration.The speaking valve was removed with difficulty using external protection and managed to breathe independently, but it became more secretive, which made ventilation difficult and made it an emergency to remove the probe so that he could be vacuumed safely.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• Manufacturer (Section G): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20620706
• Report Number: 2936999-2024-01708
• Device Sequence Number: 8905759
• Product Code: BTO
• UDI-Device Identifier: 40884522005372
• UDI-Public: 40884522005372
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K945407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

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: SSVO
• Device Catalogue Number: SSVO
• Device Lot Number: 23F0309JZX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/06/2024
• Date Device Manufactured: 06/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 24 MO
• Patient Sex: Male