MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-LHK AUGUSTA HEALTH CARE

Catalog Number	VASC1446
Medical Device Problem Codes	Decoupling (1145); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the manifold and syringe backing off when connecting.".
Additional Manufacturer Narrative
The customer reported another issue with the manifold and syringe backing off when connecting.No sample was received for evaluation; review of the finished good bill of materials/pack build and finished good manufacturing instructions did not reveal any nonconformances related to the reported defect, and the drawings for the control syringe and manifold were reviewed and determined to meet product specifications.Based on the above investigation results, the reported event was not able to be confirmed at this time.The root cause for the manifold and control syringe loose connection issues has not been determined to date, and these results will be used to determine appropriate corrective actions moving forward.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-LHK AUGUSTA HEALTH CARE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915042
• Report Number: 1417592-2026-51954
• Device Sequence Number: 5394583
• Product Code: OES
• UDI-Device Identifier: 40195327473182
• UDI-Public: 40195327473182
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: VASC1446
• 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: 03/21/2024
• Initial Report FDA Received Date: 09/28/2026
• 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