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

Model Number	70XLTCD
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	Dyspnea (1816); Unintended Extubation (4564)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: 70xltcd, 70xltcd 7.0mm xlt trach cuff dist x1 (sn:(b)(6)) 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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient produced a lot of mucus and had to remove the inner cannula eight hours after the surgery for cleaning.When the doctor tried to replace the inner cannula inside, it got stuck.There were a few millimeters to get the cannula inside, and when pushed in, it started to collapse and block the airway.The result was the same when a different inner cannula was tried.The patient struggled to breathe, but when a size six was placed inside the cannula, the patient started to breathe again normally.
Event or Problem Description
According to the reporter, the patient produced a lot of mucus and 8 hours after the surgery the inner cannula was removed for cleaning.When tried to reinsert the inner cannula, it got stuck and unable to slide in.When doctor tried to push the inner cannula in it started to collapse.During this time the patient was struggling to breath.Different inner cannula was tried and the result was the same.A size 6 was managed to placed inside the cannula and the patient started to breath normally.
Additional Manufacturer Narrative
Additional information: b5, d4(expiration date), g3, h4 correction: aware date 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 17010563
• Report Number: 8020889-2023-00098
• Device Sequence Number: 17886477
• Product Code: JOH
• UDI-Device Identifier: 20884522028162
• UDI-Public: 20884522028162
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K051416
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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: 70XLTCD
• Device Catalogue Number: 70XLTCD
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/28/2023
• Date Device Manufactured: 07/11/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Sex: Male