MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ANESTHESIA CIRCUIT-LF

Catalog Number	DYNJAA10685B
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "bh2 or general anesthesia circuit-lf- broken off at the end near the filter." "there were 2 circuits of this same lot that were found defective.".
Additional Manufacturer Narrative
The account reported finding defective filters, and it was reported that the circuit broke off on the inlet/outlet portion of the circuit where the filter is inside.A sample was received for investigation, a visual review of the sample determined that component 109889 cracked, finished good production records were reviewed, and the finished good pack build/bill of materials was reviewed.Based on the complaint details, sample evaluation, and investigation, the complaint is confirmed.The root cause for the reported issue cannot be determined; the filters already arrive connected to themselves by the manufacturer, and the only manipulation performed is to attach them to the tubing.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.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: ANESTHESIA CIRCUIT-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: madelyn ruppert ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50853358
• Report Number: 1417592-2026-47344
• Device Sequence Number: 15866057
• Product Code: CAI
• UDI-Device Identifier: 10198459372292
• UDI-Public: 10198459372292
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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
• Device Catalogue Number: DYNJAA10685B
• Device Lot Number: 25JBX325
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown