MAUDE Adverse Event Report: COVIDIEN DAR; CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Model Number	354/5876
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pipeline of the four devices had a hole, tear and slit during use.There was no reported patient outcome.
Additional Manufacturer Narrative
Concomitant products: 354/5876, 354/5876 hygroster mech fhme x25, (lot#: 24l0393fax) 354/5876, 354/5876 hygroster mech fhme x25, (lot#: 24l0394fax) 354/5876, 354/5876 hygroster mech fhme x25, (lot#: 24l0394fax).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
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the 15 mm connection was broken and a breakage in the filter case.Leak test was performed and the result is fail.It was reported that the pipeline of the four devices had a hole, tear and slit during use.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.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: DAR
• Common Device Name: CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
• Manufacturer (Section D): COVIDIEN; via g.bove, 2/4/6/8; mirandola modena,it 41037 ; IT 41037
• Manufacturer (Section G): COVIDIEN; via g.bove, 2/4/6/8; mirandola modena,it 41037 ; IT 41037
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22812221
• Report Number: 9680661-2025-00005
• Device Sequence Number: 5713255
• Product Code: BYD
• UDI-Device Identifier: 20884521056753
• UDI-Public: (01)20884521056753(17)291101(10)24L0394FAX
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K941585
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: 354/5876
• Device Catalogue Number: 354/5876
• Device Lot Number: 24L0394FAX
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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