MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-MTO,3 VALVE,KIT,MERCY MED CEN

Catalog Number	000000000651397819
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the one-way valve on the wastebag is allowing saline to leak to the the dumb bag when saline bag is pressurized.
Additional Manufacturer Narrative
The reported product problem/issue was saline leakage into the dump bag from the check valve when the saline bag is pressurized.No sample was received for evaluation; review of the finished good bill of materials/pack build, finished good manufacturing instructions, component drawing, device history record, related deviations, substitutions, inspections, labeling review, related changes, and complaint history did not reveal nonconformances or an adverse trend related to the reported defect.Based on the investigation results, the reported event was not able to be confirmed at this time as no product was returned for evaluation and testing.Root cause remains inconclusive at this time as the reported defect was not able to be confirmed, and no action is required at this time; medline will continue to monitor for additional occurrences and adverse trends.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: DBD-MTO,3 VALVE,KIT,MERCY MED CEN
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: haroon mian ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50902487
• Report Number: 1417592-2026-51334
• Device Sequence Number: 21510799
• Product Code: OEZ
• UDI-Device Identifier: 10193489076066
• UDI-Public: 10193489076066
• 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): 09/25/2026

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: 000000000651397819
• Device Lot Number: 0000101494
• Was Device Available for Evaluation?: No
• 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: 03/26/2024
• Initial Report FDA Received Date: 09/25/2026
• 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