MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V. MEDLINE; ANESTHESIA CIRCUIT-LF

Catalog Number	DYNJAA10682
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that once the circuit is attached to a mask (example mask ps# 0146260 ) the valve does not unscrew from the mask.The valve is supposed to come off so the circuit can be attached to an et tube.The right angle elbow would unscrew from the mask.After the problem occurred, another circuit was obtained to use the right-angle elbow.New mask obtained, circuit then attached to e-t tube.No adverse outcome.There were no reports of death, serious injury, medical intervention, or follow up care.
Event or Problem Description
Valve does not unscrew from the mask.

• Brand Name: MEDLINE
• Common Device Name: ANESTHESIA CIRCUIT-LF
• Manufacturer (Section D): PRODUCTOS MEDLINE S.A. DE C.V.; blvd world trade center #106; parque industrial oradel; nuevo laredo tamaulipas, 88285 ; MX 88285
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24970578
• Report Number: 1417592-2026-00534
• Device Sequence Number: 20078429
• Product Code: CAI
• UDI-Device Identifier: 10889942962389
• UDI-Public: 10889942962389
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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 Catalogue Number: DYNJAA10682
• Device Lot Number: 25LBE384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2025
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Race: White