MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; LHK,-,MID,3V,ON,PS,DT,S10RA

Catalog Number	000000000613000121
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we have experienced leaking valves, during procedures on 3 different occasions when the valve knob has been turned off, there would be continuous dripping into the waste bag.".
Additional Manufacturer Narrative
The customer reported leaking valves and that the "heparinized saline" continued to drip when the manifold valve was in the "off" position; the tubing was manually clamped to prevent the fluid from dripping, and there was no report of any serious injury, medical intervention, or follow up care related to the reported incident.Review of the finished good bill of materials, device history record, manufacturing record for the waste bag, design history file, complaint history, and quarterly trending reports did not reveal any nonconformances related to the reported defect and confirmed there have been no adverse trends; a sample or photo were not available for investigation.Based on the limited information provided and no sample to be evaluated, the reported event was not able to be confirmed at this time.Although inconclusive, a potential root cause can be attributed to over-pressurization, a psi of greater than the recommended 41kpa (300 mmhg/6 psi) usage of the closed system, and complaints will continue to be monitored via trending reports and procedure.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: LHK,-,MID,3V,ON,PS,DT,S10RA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50868839
• Report Number: 1417592-2026-48766
• Device Sequence Number: 15781495
• Product Code: OEZ
• UDI-Device Identifier: 10193489074475
• UDI-Public: 10193489074475
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/22/2026

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: 000000000613000121
• Device Lot Number: 0000139249
• 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: 03/03/2025
• Initial Report FDA Received Date: 09/23/2026
• 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