MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ANESTHESIA CIRCUIT STEWARD HLT

Catalog Number	DYNJAA23000A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that gas sampling line tubing is blocked and that he cannot blow through.
Additional Manufacturer Narrative
The doctor reported the gas sampling line tubing was blocked and he could not blow through it; this was the second one he had in a month that was like this, and another anesthesia provider in the area advised they also had the same issue with their stock.No sample or photo was received; finished good production records and finished good pack build history were reviewed, and there were no line down situations, run without approvals, substitutions, deviations, non-conformance reports, or pack build issues that might have had an impact on or would contribute to the reported issue.The reported issue was unconfirmed because a sample was required to determine cause; based on the complaint details, the root cause is considered to be a vendor product issue relating to the component manufacturing process.The quality team will monitor this issue for trending purposes, the complaint was provided to the vendor/manufacturer for further evaluation, and manufacturer/vendor investigation was received with reportability not changed.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 STEWARD HLT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945578
• Report Number: 1417592-2026-54103
• Device Sequence Number: 9623974
• Product Code: CAI
• UDI-Device Identifier: 10888277980525
• UDI-Public: 10888277980525
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/29/2026

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: DYNJAA23000A
• Device Lot Number: 25BBM921
• Was Device Available for Evaluation?: No
• 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: 05/27/2025
• Initial Report FDA Received Date: 09/30/2026
• 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