MAUDE Adverse Event Report: COVIDIEN DAR; CONNECTOR, AIRWAY (EXTENSION)

Model Number	331/5661
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Hypoventilation (1916)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
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 use, a low tidal volume alarm was triggered and the preset value could not be reached.The vital signs did not change much, but the blood oxygen was a little low for about 20 minutes.An urgent inspection of the ventilator and the entire circuit revealed an internal crack at the inner layer of the double interface of the breathing circuit.The device was immediately replaced.

• Brand Name: DAR
• Common Device Name: CONNECTOR, AIRWAY (EXTENSION)
• 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: 23885464
• Report Number: 9680661-2025-00053
• Device Sequence Number: 20016743
• Product Code: BZA
• UDI-Device Identifier: 20884522034712
• UDI-Public: (01)20884522034712(17)280501(10)23E0336FAX(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K942392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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: 331/5661
• Device Catalogue Number: 331/5661
• Device Lot Number: 23E0336FAX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2023
• 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
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 60 KG