MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ANESTHESIA CIRCUIT ADULT-LF

Catalog Number	DYNJAA10641
Medical Device Problem Codes	Gas/Air Leak (2946); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the anesthesia circuit appeared cut or damaged, triggering machine alarms for pressure leaks upon patient connection.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the anesthesia circuit appeared cut or damaged, triggering machine alarms for pressure leaks upon patient connection.
Additional Manufacturer Narrative
Update to d9, g2, g3, h3, h6, and h7.After further in/vestigation, it has been determined that a sample was returned on 12/05/2025 and the device was evaluated by the manufacturer.The report source is health professional.The original date information was received regarding this issue was received on 10/09/2025.Additional information was received by the manufacturer on 12/09/2025.The investigation involved testing of the actual/suspected device, trend analysis, and an analysis of production records.The investigation found a leakage/seal problem and the cause has been traced to a manufacturing deficiency.The associated recall numbers are r-25-215-fg and r-25-215-fgx1.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: ANESTHESIA CIRCUIT ADULT-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 23478438
• Report Number: 1417592-2025-00600
• Device Sequence Number: 18699042
• Product Code: CAI
• UDI-Device Identifier: 10889942841226
• UDI-Public: 10889942841226
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJAA10641
• Device Lot Number: 25EBK360
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown