MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP-NAMIC MEDLINE; LHK-MEADOWVIEW,REG

Catalog Number	VASC1263
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "8mm control syringe backing off the manifold" and "syringe won't tighten as usual and backs off on its own." according to the facility contact, repeated tightening of the syringe was required to maintain patency.There were "no issues/harm" reported to the individual or user.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that "8mm control syringe backing off the manifold" and "syringe won't tighten as usual and backs off on its own.".

• Brand Name: MEDLINE
• Common Device Name: LHK-MEADOWVIEW,REG
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP-NAMIC; 10 glen falls technical park; glen falls NY 12801 3864
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24728178
• Report Number: 3015910259-2026-00104
• Device Sequence Number: 21437957
• Product Code: OEZ
• UDI-Device Identifier: 10195327000080
• UDI-Public: 10195327000080
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: VASC1263
• Device Lot Number: 24IBI957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown