MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-LHK-,HMWB/HMTW HOSPITAL

Catalog Number	VASC1307
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported product problem/issue was a check valve leaking into the dump bag.A used sample was returned for evaluation and visual evaluation did not reveal any defects; an unused sample was returned for evaluation and functional evaluation was performed by connecting the waste bag assembly to a pressurized saline bag, pressurizing the saline bag to the recommended 'green' area, 300 mmhg / 6psi of the pressure gauge and observing for any leaks or dispensing of silicone pushing into the waste bag.Review of the finished good bill of materials/pack build, finished good manufacturing instructions, component drawing, and device history record did not reveal nonconformances related to the reported defect, and the sample was found to function as intended with no saline pushed into the waste bag.The reported event was not able to be confirmed at this time; although inconclusive, possible root cause can be attributed to a psi of greater than the recommended 41kpa (300 mmhg/6 psi) usage of the closed system, and no action is required at this time as the reported event was not able to be confirmed.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.
Event or Problem Description
It was reported that waste bag leaking.

• Brand Name: MEDLINE
• Common Device Name: DBD-LHK-,HMWB/HMTW HOSPITAL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi pinnamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50930978
• Report Number: 1417592-2026-52844
• Device Sequence Number: 16142192
• Product Code: OEZ
• UDI-Device Identifier: 40195327057856
• UDI-Public: 40195327057856
• 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): 09/25/2026

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: VASC1307
• Device Lot Number: 24ABC832
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/18/2024
• 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: 04/10/2024
• Initial Report FDA Received Date: 09/29/2026
• 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