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

Catalog Number	DYNJAA10325C
Medical Device Problem Codes	Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "obstruction in the co line of the anesthesia kits.The needle will not advance".
Additional Manufacturer Narrative
The customer reported that "plastic occlusion" inside the co2 lines were discovered multiple times; the customer "changed out the co2 line connected to the circuit" and the machine "began to measure co2." a photo was received for the investigation, finished good production records were reviewed, finished good pack build was reviewed, trending was reviewed, and the manufacturer completed a review of the production records.Based on the complaint details, photo evaluation, and the investigation, the complaint is not confirmed; it is not possible to evaluate the provided photo for the reported defect.The manufacturer did not find any discrepancies or defects in their production records that could have contributed or caused the reported issue, and the division will monitor this issue for trending purposes.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: ANESTH CIRCUIT ADULT-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50934856
• Report Number: 1417592-2026-53418
• Device Sequence Number: 9563757
• Product Code: CAI
• UDI-Device Identifier: 10193489442366
• UDI-Public: 10193489442366
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/28/2026

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: DYNJAA10325C
• Device Lot Number: 25IBF995
• 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: 11/06/2025
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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