MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; LHK CENTRAL FLORIDA CARDIO

Catalog Number	VASC1459
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility "the control syringe supposedly doesn't stay connected well enough to the manifold once attached and loosens, therefore causing issues with air bubbles and leaks".Per the facility there is no noted defect in the syringe.Per the facility this occurs before patient use when they are preparing for procedures.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
According to the facility "the control syringe supposedly doesn't stay connected well enough to the manifold once attached and loosens, therefore causing issues with air bubbles and leaks".

• Common Device Name: LHK CENTRAL FLORIDA CARDIO
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21048733
• Report Number: 3015910259-2024-00046
• Device Sequence Number: 11615330
• Product Code: OEQ
• UDI-Device Identifier: 40195327509782
• UDI-Public: 40195327509782
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/31/2024

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: VASC1459
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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