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

Catalog Number	DYNJAA10997
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reporter stated that the components did not fit snugly together and came apart very easily while in use, and clarified that the yankauer would disconnect from the suction tubing while they were suctioning the patient; there were not any adverse events reported, there was no harm to the patient, and no medical intervention, serious injury, or follow-up care was reported.A sample consisting of one suction tubing and one yankauer suction tip was received; the id and od were measured on both and all measurements met specifications, the tubing and yankauer were connected to each other and then to a suction machine, 500cc of fluid were suctioned, and the connection remained secure for the entire test.The packs production record and pack build history were reviewed, with no line down situations, run without approvals, substitutions, deviations, non-conformance reports, or pack build issues that might have had an impact on this issue; trending found 0 additional reported complaints for this issue for the account in the past 24 months.Medline was not able to confirm the quality issue reported, the cause was documented as not confirmed with 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.
Event or Problem Description
It was reported that "these 2 components do not fit snugly together.They come apart very easily while in use.".

• Brand Name: MEDLINE
• Common Device Name: DBD-ANESTHESIA CIRCUIT EXP-LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rylee rosenberg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884013
• Report Number: 1417592-2026-49924
• Device Sequence Number: 9827099
• Product Code: CAI
• UDI-Device Identifier: 40195327205714
• UDI-Public: 40195327205714
• 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): 09/23/2026

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: DYNJAA10997
• Device Lot Number: 24HBJ977
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/15/2024
• 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: 11/12/2024
• Initial Report FDA Received Date: 09/24/2026
• 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