MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; OUTER CANISTER, SOFT LINER, 1500CC

Catalog Number	DYNDCLO1500
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "rigid outer canniser -cracked or chipped.".
Additional Manufacturer Narrative
The complaint transcript stated, "rigid outer canniser -cracked or chipped," and the reported issue was cracked canisters.A sample was received for investigation; seven (7) ea were received without their original packaging, and visual inspection observed that all seven (7) ea exhibited small cracks on the bottom of the canister.Based on the complaint details, sample evaluation, and investigation, the complaint has been confirmed.The lot information was not provided, the vendor cannot be identified, a device history record review cannot be requested, and no information was available regarding the storage and handling conditions of the items; as a result, the root cause of this issue cannot be determined at this time.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: OUTER CANISTER, SOFT LINER, 1500CC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: michael albrecht ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50754171
• Report Number: 1417592-2026-39179
• Device Sequence Number: 15740398
• Product Code: KDQ
• UDI-Device Identifier: 10884389129593
• UDI-Public: 10884389129593
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/09/2026

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: DYNDCLO1500
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/18/2026
• 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: 03/02/2026
• Initial Report FDA Received Date: 09/14/2026
• 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