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

Model Number	126035
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, prior to use, the two endotracheal tubes and four broncho catheters had an air leakage in the cuff.There was no patient involvement.
Additional Manufacturer Narrative
D10 concomitant products: 118-65m, 118-65m 6.5mm safety flex cuffed murphy, (lot#: 202308116x) 125032, 125032 32fr lt bronco cath pu cuff x1, (lot#: 202311197x) 125037, 125037 37fr lt bronco cath pu cuff x1, (lot#: 202402099x) 125035, 125035 35fr lt bronco cath pu cuff x1, (lot#: 202001425x) 118-70m, 118-70m 7.0mm safety flex cuffed murphy, (lot#: 202401426x).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 and h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the sample was contaminated however no signs of defect were detected.The returned unit was inflated and deflated using a syringe and there was no issue noted during inflation or deflation.The returned unit was inflated and deflated three times and no leakage was detected.It was reported that the two endotracheal tubes and four broncho catheters had an air leakage in the cuff.It was stated that the cuff could not inflate to a full elastic state, and the cuff did not rebound when pinched it once when tested.The reported issue could not be confirmed.The product analysis noted evidence that the device was not used as intended.It was determined that the most likely cause was the end user may have left the inflation device in the inflation valve.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: test the cuffs, pilot balloons and valves of each tube by inflation prior to use.Insert a luer tip syringe into each cuff inflation valve housing and inject enough air to fully inflate the cuffs.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: 20736589
• Report Number: 8020889-2024-00235
• Device Sequence Number: 18236980
• Product Code: BTS
• UDI-Device Identifier: 10884522028950
• UDI-Public: 10884522028950
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2025

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: 126035
• Device Catalogue Number: 126035
• Device Lot Number: 202307396X
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2023
• 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