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

Catalog Number	DYNJAA10641
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, "the anesthesia circuits appear to be either cut or damaged" causing the "machines to alarm with a pressure leak".The customer did not report any patient impact or adverse health effect related to the reported issue.
Additional Manufacturer Narrative
According to the customer, "the anesthesia circuits appear to be either cut or damaged" causing the "machines to alarm with a pressure leak".The customer did not report any patient impact or adverse health effect related to the reported issue.The customer did not report any serious injury, medical intervention, or follow-up care related to the reported incident.No additional details are available related to the customer reported issue.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 medwatch is being filed.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; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23491190
• Report Number: 1417592-2025-00611
• Device Sequence Number: 8552003
• 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
• Type of Report: Initial
• Report Date (Section B): 11/06/2025

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
• Date Returned to Manufacturer: 10/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 11/06/2025
• 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