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

Model Number	125035
Medical Device Problem Codes	Use of Device Problem (1670); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction

• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50782167
• Report Number: 8020889-2026-00259
• Device Sequence Number: 10510666
• Product Code: BTS
• UDI-Device Identifier: 40884522008731
• UDI-Public: (01)40884522008731(17)300601(10)202506036X
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 125035
• Device Catalogue Number: 125035
• Device Lot Number: 202506036X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 06/04/2025
• 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