MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; LHK,US,CENTRA STATE HEALTHCARE

Catalog Number	VASC1461
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility on 7/25, "lhk was being set up for a case and it wouldn't tighten.It seemed like it was the syringe connection.The staff relayed the defect a few days after they threw the manifold away and replaced it with a new one with no other incidents.".
Additional Manufacturer Narrative
According to the facility on 7/25, "lhk was being set up for a case and it wouldn't tighten.It seemed like it was the syringe connection.The staff relayed the defect a few days after they threw the manifold away and replaced it with a new one with no other incidents.This occurred prior to use- when prepping the manifold for the case.There was no patient involvement, no impact to the patient, and the procedures were completed".Multiple instances were reported by the facility, however at this time a definitive number was not provided.This medwatch will account for all reported incidences.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)(6) 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.
Additional Manufacturer Narrative
Updated h6: investigation conclusions.

• Common Device Name: LHK,US,CENTRA STATE HEALTHCARE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20043197
• Report Number: 3015910259-2024-00031
• Device Sequence Number: 20822143
• Product Code: OES
• UDI-Device Identifier: 40195327513017
• UDI-Public: 40195327513017
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 08/23/2024

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: VASC1461
• Device Lot Number: 24EBP218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 08/23/2024
• 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 Age: 40 YR
• Patient Sex: Female
• Patient Weight: 175 KG