MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CANISTER,SUCTION,850 CC W/FLOAT LID

Catalog Number	HCS7850H
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the suction stopped working.The hose from her trach isn't working".
Additional Manufacturer Narrative
The patient's sister reported that the suction stopped working and that the hose from the patient's trach isn't working; according to the customer, the "suction motor" works intermittently and sometimes has "weak" suction.No sample or photo was received for the investigation, review of previous trend reports found no trends, and the complaint was determined to be related to the suction aspirator, not the canister.Due to not receiving the actual sample, medline was not able to confirm what may have caused the issue, and the cause was documented as sample required to determine cause.The complaint was provided to the component manufacturing facility for further evaluation for the suction aspirator, and the complaint review process has been completed.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: CANISTER,SUCTION,850 CC W/FLOAT LID
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joachim kamanda ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50854805
• Report Number: 1417592-2026-47591
• Device Sequence Number: 10053653
• Product Code: KDQ
• UDI-Device Identifier: 10884389144565
• UDI-Public: 10884389144565
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/21/2026

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: HCS7850H
• 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: 01/08/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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