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

Catalog Number	DYNJAA0380A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hypoventilation (1916)
Date of Event	08/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, there are "cracks in the circuit after being attached to a patient, following successful passing of safety check and patient induction.Anesthesia machine notifies of circuit leak and extreme reduction in ability to ventilate patient." per the facility, "circuit is immediately replaced.No major harm, however patients had reduced oxygenation due to extreme reduction in ability to ventilate." 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
According to the facility, there are "cracks in the circuit after being attached to a patient, following successful passing of safety check and patient induction.Anesthesia machine notifies of circuit leak and extreme reduction in ability to ventilate patient." per the facility, "circuit is immediately replaced.No major harm, however patients had reduced oxygenation due to extreme reduction in ability to ventilate." 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.

• Common Device Name: ANESTHESIA CIRCUIT ADULT-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield 60093
• MDR Report Key: 22912450
• Report Number: 1417592-2025-00426
• Device Sequence Number: 9047815
• Product Code: CAI
• UDI-Device Identifier: 10195327478285
• UDI-Public: 10195327478285
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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
• Device Catalogue Number: DYNJAA0380A
• Device Lot Number: 25FBT875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 08/28/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown