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

Catalog Number	OR212H
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the lids are stuck on the canister itself and we are unable to remove it safely with out breaking the canister.These usually come in separated but for these they are already put together.".
Additional Manufacturer Narrative
The customer reported that the lids are stuck on the canister itself and they were unable to remove them safely without breaking the canister.Medline quality received 10 samples for evaluation, and a functional inspection was conducted with the provided samples.It was found that the lids are closed tightly, but no abnormalities were found in removing the lids from the canister; at this time, the reported concern could not be confirmed, as the samples functioned normally.No root cause was identified, and a retrospective review of the past year indicated that there have been no prior complaints in regard to this issue.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: maya mcknight ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945501
• Report Number: 1417592-2026-54090
• Device Sequence Number: 10429534
• Product Code: KDQ
• UDI-Device Identifier: 10888277363342
• UDI-Public: 10888277363342
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/28/2026

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: 68122062315C
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/13/2023
• 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: 09/06/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown