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

Model Number	610U5257
Medical Device Problem Codes	Break (1069); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient in cticu "[cardio-thoracic intensive care unit]" underwent bedside percutaneous tracheostomy.The ventilator was plugged into bronch adapter (covidien dar connector, ref 610u5257, lot 25g0004fax, exp 7/1/2030) during procedure.Once tracheostomy tube was inserted, we attempted to disconnect vent circuit from the bronch adapter, but the bronch adapter broke off into the vent circuit and could not be removed.Patient was bagged with bvm "[bag-valve-mask]" without any complication and rt "[respiratory therapist]" got new vent circuit.No harm met the patient, but this was a device failure causing obstruction of ventilator tubing.

• Brand Name: DAR
• Common Device Name: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): Covidien; 200 medtronic dr; lafayette CO 80026
• MDR Report Key: 50914753
• Report Number: 50914753
• Device Sequence Number: 20166042
• Product Code: BZA
• UDI-Device Identifier: 10884522039314
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/02/2026
• Report Date (Section F): 09/02/2026

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: 610U5257
• Device Lot Number: 25G0004FAX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 09/02/2026