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

Model Number	60XLTCD
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Distress (2329); Unintended Extubation (4564)
Date of Event	12/24/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that during a routine patient check, the flange of the tracheostomy tube disconnected from the tube while in use with one pin was broken.The patient, who was on a ventilator experienced distress and bleeding from the tracheostomy site throughout the night.The patient did not have any unusual airway anatomy, and a trach cleaning kit was used for cleaning the tubes.The event did not result in a delay of any procedure or surgery.Following the replacement of the tube and airway management with cold lavage, the patient¿s condition stabilized and recovered within 10 minutes.
Additional Manufacturer Narrative
Additional information: g3, imf code (delay to treatment/therapy and device revision or replacement), fdp code (delay to treatment/therapy).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: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that one of the slots for the pivot pins on the bottom part of the xlt head was broken, and the flange was disconnected from the xlt head bottom, however the pivot pins on the flange were still intact.Further examination of the broken surface showed that the slot was broken with undue force using a sharp object or utensil.The broken piece was not returned for evaluation.It was reported that the flange of the tracheostomy tube disconnected from the tube while in use with one pin was broken.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.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: during and after attachment of respiratory or anesthesia tubing connectors to the shileytm inner cannula xlt, avoid application of e xcessive rotational, linear, or rocking forces on the tubing and/or connectors to prevent damage to the tracheostomy tube.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: 21121344
• Report Number: 8020889-2025-00024
• Device Sequence Number: 12932375
• Product Code: JOH
• UDI-Device Identifier: 20884522028193
• UDI-Public: 20884522028193
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2025

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: 60XLTCD
• Device Catalogue Number: 60XLTCD
• Device Lot Number: 48623100001
• 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: 12/26/2024
• Supplement Date Received by Manufacturer: 01/21/2025; 04/11/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 01/24/2025; 04/15/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 77 YR
• Patient Sex: Unknown
• Patient Weight: 93 KG