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

Model Number	10CN10R
Medical Device Problem Codes	Use of Device Problem (1670); Gas/Air Leak (2946)
Health Effect - Clinical Codes	Discomfort (2330); Unintended Extubation (4564)
Date of Event	07/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, the balloon of the tracheostomy tube was deflated prematurely.The patient had to change the trach tube every week or every 15 days instead of once a month resulted to discomfort.Upon visual examination, the nurse reported that the balloon was 'wrinkled' and when it was inflated with syringe, a leaked balloon was observed.
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.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
Evaluation summary: medtronic conducted an investigation based upon all information received.Two devices were available for evaluation.Visual inspection noted that there was a straight-line slit measuring 0.48mm in length on the main body of the cuff on one sample while a straight slit measuring 1.05mm in length was noted on the cuff of another sample.Functional testing found that the that the cuff was 'wrinkled' and when it was inflated with syringe, a leaked cuff was observed.It was reported that the cuff of the tracheostomy tube was deflated prematurely.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when the cuff body came in contact with a sharp utensil or object.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.
Event or Problem Description
According to the reporter, the cuff of the tracheostomy tube was deflated prematurely.The patient had to change the trach tube every week or every 15 days instead of once a month resulted to discomfort.Upon visual examination, the nurse reported that the cuff was 'wrinkled' and when it was inflated with syringe, a leaked cuff was observed.
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.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: 20220973
• Report Number: 8020889-2024-00181
• Device Sequence Number: 7494450
• Product Code: JOH
• UDI-Device Identifier: 10884521205475
• UDI-Public: 10884521205475
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2025

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: 10CN10R
• Device Catalogue Number: 10CN10R
• Device Lot Number: 202403096X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 11/22/2024; 01/15/2025
• Initial Report FDA Received Date: 09/15/2024
• Supplement Report FDA Received Date: 12/05/2024; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown