MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CANISTER, RIGID, 1200CC

Catalog Number	OR212H
Medical Device Problem Codes	Material Discolored (1170); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "discolored cylinder.The customer has several reports of these cylinders not working correctly due to what the associates think is a check valve issue.".
Additional Manufacturer Narrative
The account reported a discolored cylinder and several reports of these cylinders not working correctly due to what the associates think is a check valve issue.A photo was received for investigation; upon visual review, no issues were identified, and since the reported problem is functional in nature, a physical sample is required for further evaluation.Based on the complaint details, picture evaluation, and investigation, the complaint cannot be confirmed at this time.Cause is unconfirmed; sample required to determine cause, and the division will continue to monitor the 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, 1200CC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: koushik pothamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50918866
• Report Number: 1417592-2026-52443
• Device Sequence Number: 5999181
• Product Code: KDQ
• UDI-Device Identifier: 10888277363342
• UDI-Public: 10888277363342
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/25/2026

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: OR212H
• Device Lot Number: 34624120302B
• Was Device Available for Evaluation?: Yes
• 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: 07/23/2025
• Initial Report FDA Received Date: 09/28/2026
• 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