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

Catalog Number	DYNJAA6040
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the gas sample line in this kit could not read c02 from patient monitor".
Additional Manufacturer Narrative
The account reported that the gas sample line in this kit could not read c02 from the patient monitor, they replaced the sample line with a smith medical line that ended up working, and dr.Jacob¿s surgery was ultimately canceled for other reasons outside of this issue.A sample was received for investigation; several gsl samples were received, all gsl were tested for occlusion, air was able to pass through all of the lines with no issue, and there was no visible issue with the openings.The packs production record and pack build history were reviewed, and there were no issues that would contribute to the reported issue.We are not able to confirm the quality issue with the gas sampling lines; the cause was not confirmed with the received sample, 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: ADULT ANESTHESIA CIRCUIT-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50774743
• Report Number: 1417592-2026-40750
• Device Sequence Number: 13366137
• Product Code: CAH
• UDI-Device Identifier: 40080196841463
• UDI-Public: 40080196841463
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K925217
• 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): 09/11/2026

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: DYNJAA6040
• Device Lot Number: 22KBC473
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/20/2023
• 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: 10/09/2023
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (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