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

Catalog Number	DYNJAA0392
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "some of our circuit masks have come bent".
Additional Manufacturer Narrative
The account reported that some circuit masks had come bent.A sample was received for investigation; the sample consisted of seven masks, each of the masks has some degree of warping on the shell/frame, and some masks have a warped connection port.Finished good production records and finished good pack build were reviewed, and there were no issues identified that would contribute to the reported issue; the reported problem was confirmed based on the sample evaluation.Based on the complaint details, the root cause is considered to be a vendor product issue relating to the component manufacturing/storage process, and the complaint was provided to the component manufacturing facility for further evaluation while 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: DBD-ANESTHESIA CIRCUIT ADULT-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield 60093 -275
• Manufacturer Contact: koushik pothamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50856875
• Report Number: 1417592-2026-47968
• Device Sequence Number: 10025968
• Product Code: CAI
• UDI-Device Identifier: 40195327545476
• UDI-Public: 40195327545476
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/22/2026

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: DYNJAA0392
• Device Lot Number: 24CBP453
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2024
• 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: 06/06/2024
• Initial Report FDA Received Date: 09/22/2026
• 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