MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CANISTER, RIGID, 3000CC

Catalog Number	OR230
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Explosion (4006)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "4 cracked suction canisters and 1 suction canister actually exploded all over the operating room.".
Additional Manufacturer Narrative
The customer contact reported that the canisters were leaking due to cracks in the plastic, and then one exploded all over the room; the customer contact stated there was no harm done to a person.No sample or photo was received for the investigation; finished good production records were reviewed, all product performance test records met the applicable qualification and acceptance standards, six retained samples were visually inspected with no appearance-related defects observed, and full performance testing on the retained samples met the specified requirements and passed testing.At this time, medline was unable to confirm the reported defect, as no physical sample or detailed photographic evidence was provided to support the investigation.Sample was required to determine cause, and there has been no change to the reportability decision associated with this complaint.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, 3000CC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50675487
• Report Number: 1417592-2026-34289
• Device Sequence Number: 18749319
• Product Code: KDQ
• UDI-Device Identifier: 10888277363366
• UDI-Public: 10888277363366
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/04/2026

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: OR230
• Device Lot Number: 68125084721C
• 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: 03/11/2026
• 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