MAUDE Adverse Event Report: COVIDIEN AG JUAREZ (MMJ) SHILEY; STYLET, TRACHEAL TUBE

Model Number	85864
Medical Device Problem Codes	Defective Device (2588); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing, a physician provided feedback regarding the ten stylets, describing as an unacceptable replacement due to being too flimsy, not holding shape, and breaking off easily.There was no patient involved.
Additional Manufacturer Narrative
D10 concomitant product: 85864 stylet sterile 10fr bx20 x20 lot: unknown, 85864 stylet sterile 10fr bx20 x20 lot: unknown, 85864 stylet sterile 10fr bx20 x20 lot: unknown, 85864 stylet sterile 10fr bx20 x20 lot: unknown, 85864 stylet sterile 10fr bx20 x20 lot: unknown, 85864 stylet sterile 10fr bx20 x20 lot: unknown, 85864 stylet sterile 10fr bx20 x20 lot: unknown, 85864 stylet sterile 10fr bx20 x20 lot: unknown, 85864 stylet sterile 10fr bx20 x20 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, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Picture evaluation noted that the stylet had several bents.It was reported that a physician provided feedback regarding the ten stylets, describing as an unacceptable replacement due to being too flimsy, not holding shape, and breaking off easily.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: this product cannot be adequately cleaned and/or sterilized by the user in order to facilitate safe reuse and is therefore intended for single use.Attempts to clean or sterilize these devices may result in a bio incompatibility, infection or product failure risks to the patient.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: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer (Section G): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21899759
• Report Number: 9681384-2025-00431
• Device Sequence Number: 8794800
• Product Code: BSR
• UDI-Device Identifier: 10884522004084
• UDI-Public: 10884522004084
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: 85864
• Device Catalogue Number: 85864
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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