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

Catalog Number	DYNJAA10763A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "where the mask would connect to the elbow of circuit.They are "warped" to the point we have crnas that can¿t get the mask to connect to circuit.".
Additional Manufacturer Narrative
The account reported finding a warped mask where the mask would connect to the elbow of circuit and crnas can¿t get the mask to connect to circuit.Medline quality received six units of dynjaa10763a circuit kits; the mask component size 5 were visually inspected for signs of damage, defects or deformities, and finished good production records and finished good pack build were reviewed.The masks have a warped connection port; the root cause could not be determined based on the complaint information and samples provided and based on the complaint details the root cause is considered to be a vendor product issue relating to the component manufacturing process.Our quality team will monitor this issue for trending purposes, and reportability has 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: DBD-ANESTHESIA CIRCUIT ADULT-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azra halilovic ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50866893
• Report Number: 1417592-2026-48503
• Device Sequence Number: 13430377
• Product Code: OFP
• UDI-Device Identifier: 10198459109706
• UDI-Public: 10198459109706
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/22/2026

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: DYNJAA10763A
• Device Lot Number: 25DBN786
• 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: 09/04/2025
• Initial Report FDA Received Date: 09/23/2026
• 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