MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CANISTER,SUCTION,1200 CC W/FLOAT LID

Catalog Number	HCS7120
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the lids do not fit.They look like they should but are ever so slightly to big.They tried pressing down and it will not seal.".
Additional Manufacturer Narrative
The customer states the lids do not fit, they look like they should but are ever so slightly to big, and they tried pressing down and it will not seal.A sample was received for the investigation; medline received two cases, the units inside were in good condition, tested the samples by placing the lids on the canisters and pushing down, attached the caps to the patient, ortho, and accessory ports, attached the suction tubing to the vacuum port, and using a suction aspirator could hear an audible snap indicating the lid was sealed to the canister.Medline was not able to confirm what may have caused the lids not to fit, and the cause was not confirmed with received sample.The instructions for use found inside the boxes were a previous version and have since been updated; 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: CANISTER,SUCTION,1200 CC W/FLOAT LID
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946467
• Report Number: 1417592-2026-54264
• Device Sequence Number: 9499226
• Product Code: KDQ
• UDI-Device Identifier: 40888277104717
• UDI-Public: 40888277104717
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/30/2026

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: HCS7120
• Device Lot Number: 67022064504
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/27/2023
• 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: 09/20/2023
• Initial Report FDA Received Date: 09/30/2026
• 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