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

Catalog Number	DYNJAA10261B
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "a number of anesthesiologists are having difficulties with certain faulty circuits" and "initially, it passes the leak test, however it fails to hold pressure once it is hooked up and used on a patient.".
Additional Manufacturer Narrative
It was reported that the circuits failing and reported that the circuit "fails to hold pressure once it is hooked up and used on a patient." medline quality received one sample; the sample was visually inspected and there were no signs of damage, defects or deformities, the expendable tubing was extended to its full length, the circuit was connected to an air source, and a leak was detected on the expandable tubing side with no filter attached to it.The reported problem was confirmed based on the detected leak; however, medline stated it "cannot determine a true root cause" and also stated the root cause is considered to be a vendor product issue relating to the component manufacturing process.The complaint was provided to the vendor/manufacturing site for further evaluation, and the quality team 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: ANESTHESIA CIRCUIT - LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50872507
• Report Number: 1417592-2026-49325
• Device Sequence Number: 13067264
• Product Code: CAI
• UDI-Device Identifier: 10193489430783
• UDI-Public: 10193489430783
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/22/2026

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: DYNJAA10261B
• Device Lot Number: 25ABV276
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/29/2025
• 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: 04/23/2025
• Initial Report FDA Received Date: 09/23/2026
• 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