MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CIRCUIT,ANES,UNILIMB,W/HME,LF

Catalog Number	DYNJAAF6463
Medical Device Problem Codes	Gas/Air Leak (2946); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "anes circuits that are pv are having issues with some of the medline circuits causing a leak test failure during the fda required leak test on our anesthesia machines.Additional problems/complaints from staff are that the masks are cheap and often bent or misshaped causing difficulty in mask ventilation.".
Additional Manufacturer Narrative
It was reported that "anes circuits that are pv are having issues with some of the medline circuits causing a leak test failure during the fda required leak test on our anesthesia machines.Additional problems/complaints from staff are that the masks are cheap and often bent or misshaped causing difficulty in mask ventilation." 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: CIRCUIT,ANES,UNILIMB,W/HME,LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: hnin phyu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50872692
• Report Number: 1417592-2026-49344
• Device Sequence Number: 21188537
• Product Code: CAI
• UDI-Device Identifier: 40884389624556
• UDI-Public: 40884389624556
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 09/10/2026

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: DYNJAAF6463
• Device Lot Number: 23JBH342
• 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: 04/18/2024
• Initial Report FDA Received Date: 09/23/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown