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

Catalog Number	DYNJAP10133
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, after induction and intubation, there was a circuit leak alarm on the anesthesia ventilator.After troubleshooting the ett, a defect in the circuit was discovered, where air was noticeably flowing out of a warped portion of the circuit that had a perforation.
Additional Manufacturer Narrative
It was reported that, after induction and intubation, there was a circuit leak alarm on the anesthesia ventilator.After troubleshooting the ett, a defect in the circuit was discovered, where air was noticeably flowing out of a warped portion of the circuit that had a perforation.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.

• Brand Name: MEDLINE
• Common Device Name: ANESTHESIA CIRCUIT PEDS - LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nithla mathivanan ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25626773
• Report Number: 1417592-2026-03070
• Device Sequence Number: 15706155
• Product Code: CAI
• UDI-Device Identifier: 10198459353338
• UDI-Public: 10198459353338
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: DYNJAP10133
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Female