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

Catalog Number	DYNJAA10634
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "in the last three weeks we had 3 incidents with our circuits from medline.In each of the incidents the circuit broke of right at the connection circuit and filter when pulled at.".
Additional Manufacturer Narrative
The account reported that in each incident, the circuit broke off right at the connection circuit and filter when pulled at; the circuit broke prior to patient use and there was no impact to the patient/user.A sample was received and consisted of one dynjaa10634 circuit not in its original packaging; on one of the limbs of the circuit, there was a separation between the corrugated tubing and a bacteria filter at the first corrugation below the filter, with no signs of stretching, wear, rips, or tears.The issue could not be replicated; finished good production records and pack build history were reviewed and there were no issues that would contribute to the reported issue.Medline was not able to confirm a root cause.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 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 reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-ANESTHESIA CIRCUIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931361
• Report Number: 1417592-2026-52875
• Device Sequence Number: 10725359
• Product Code: CAI
• UDI-Device Identifier: 40888277786708
• UDI-Public: 40888277786708
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: DYNJAA10634
• Device Lot Number: 23DBG177
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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