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

Catalog Number	HCS7850
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that she has to poke a hole in the canister/lid in order for the suction to work.
Additional Manufacturer Narrative
The customer reported that the suction does not work and have to poke a hole in the lid to do so.Medline quality received one canister with the lid fully sealed and nine unused canisters; visual inspection found seven were in new condition and two were cracked around the lip of the canister, and testing with an hcs7000 suction aspirator found the unit turned on and the lid was firmly sealed in place.As a result, medline cannot confirm the reported complaint as the suction canisters appear to be working as they should, and the cause was not confirmed with received sample.The division will monitor for trends.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: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50275596
• Report Number: 1417592-2026-17898
• Device Sequence Number: 15969648
• Product Code: KDQ
• UDI-Device Identifier: 40884389144566
• UDI-Public: 40884389144566
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/17/2026

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: HCS7850
• Device Lot Number: 67022084502
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/15/2023
• 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: 02/06/2023
• Initial Report FDA Received Date: 08/17/2026
• 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