MAUDE Adverse Event Report: MALLINCKRODT MEDICAL SHILEY; TUBE, BRONCHIAL (W/WO CONNECTOR)

Model Number	125028
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuffs of the bronco catheters had an air leak prior to use.There was no patient involvement.
Additional Manufacturer Narrative
Concomitant products: 125028, 125028 28fr lt bronco cath pu cuff x1, (lot# 202008026x) 125028, 125028 28fr lt bronco cath pu cuff x1, (lot# 202006377x) 125028, 125028 28fr lt bronco cath pu cuff x1, (lot# 202007434x) 125028, 125028 28fr lt bronco cath pu cuff x1, (lot# 202304062x) 125028, 125028 28fr lt bronco cath pu cuff x1, (lot# 202008026x) 125028, 125028 28fr lt bronco cath pu cuff x1, (lot# 202008026x) 125028, 125028 28fr lt bronco cath pu cuff x1, (lot# 202006377x) 125028, 125028 28fr lt bronco cath pu cuff x1, (lot# 202007434x) 125028, 125028 28fr lt bronco cath pu cuff x1, (lot# 202007434x).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: d4(udi), d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device including two suctions and one opti-port connector assembly without their original unit packs were available for evaluation.An attempt to inflate the returned unit, as per the set parameters, failed because the tracheal cuff could not be inflated.Examination of the cuff body under the microvu revealed the presence of a slit.This type of damage is indicative of the cuff body having come into contact with a sharp instrument or object.It was reported that the cuffs of the bronco catheters had an air leak prior to use.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.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: various bony anatomical structures (e.G., teeth) within the intubation route or any intubation tools with sharp surfaces present a threat to maintaining cuff integrity.Care must be taken to avoid damaging the thin-walled cuffs during intubation which would create the need to subject the patient to the trauma of extubation and re-intubation.If either cuff is damaged, the tube should not be used.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, BRONCHIAL (W/WO CONNECTOR)
• 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: 22290662
• Report Number: 8020889-2025-00305
• Device Sequence Number: 15533511
• Product Code: BTS
• UDI-Device Identifier: 40884522008717
• UDI-Public: (01)40884522008717(17)250701(10)202007434X
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K771219
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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 Expiration Date: 07/01/2025
• Device Model Number: 125028
• Device Catalogue Number: 125028
• Device Lot Number: 202007434X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2020
• 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 H11
• Patient Sex: Unknown