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

Catalog Number	DYNJAA9915C
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "our anesthesia sample line is defective in several of our circuit packs.The end has plastic that is not punctured and it is causing our anesthesia machines to fail.".
Additional Manufacturer Narrative
The account reported that the anesthesia sample line was defective in several circuit packs and the end had plastic that was not punctured, causing anesthesia machines to fail.A sample was received, and medline tested the line to confirm if air could pass through it; air was not able to pass through the line, and visual inspection from the luer lock end found a visible difference in the openings, with one end appearing to show that the tubing does not go all the way through the luer lock connection port.The reported problem was confirmed, and the root cause is considered to be a vendor product issue relating to the component manufacturing process; the manufacturer reply stated that improper operation practice in the connection process and too much cyclohexanone applied may cause the blockage.The complaint was provided to the component manufacturing facility for further evaluation, the quality team will monitor this issue for trending purposes, and no medical intervention, serious injury, or follow-up care has been reported.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: DBD-CIRCUIT ADULT ANESTHESIA-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50947159
• Report Number: 1417592-2026-54405
• Device Sequence Number: 9552093
• Product Code: CAI
• UDI-Device Identifier: 40193489366588
• UDI-Public: 40193489366588
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: DYNJAA9915C
• Device Lot Number: 24GBU193
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/24/2024
• 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: 09/24/2024
• Initial Report FDA Received Date: 09/30/2026
• 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