MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CANISTER, RIGID, 2000CC

Catalog Number	OR220
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rn noticed that it stopped suctioning urine.Andrew, an icu cna, noticed that it would suction a little bit if he disconnected then reconnected suctioning, but then would stop again.
Additional Manufacturer Narrative
The cannister was used for a purewick and the rn noticed that it stopped suctioning urine and the patient was soiled; an icu cna noticed that it would suction a little bit if he disconnected then reconnected suctioning, but then would stop again.Medline quality received 1 ea of or220 for evaluation, and the video provided was reviewed and it was found the device was malfunctioning.At this time, the reported concern was confirmed, as the device shown in the video was not functioning properly.The suspected root cause is undetermined at this time, and the division will continue to monitor this issue for trending.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, RIGID, 2000CC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: daniel soto ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50668589
• Report Number: 1417592-2026-33625
• Device Sequence Number: 15990867
• Product Code: KDQ
• UDI-Device Identifier: 40888277363350
• UDI-Public: 40888277363350
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/03/2026

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: OR220
• Device Lot Number: 34623124411B
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/27/2024
• 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: 05/09/2024
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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