MAUDE Adverse Event Report: PRODUCTOS MEDLINE, S.A. DE C.V; LHK, US, JERSEY SHORE MEDICAL

Catalog Number	VASC1453
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility the control syringe is coming off of the manifold.No additional information was provided by the facility after multiple attempts.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 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 is coming off of the manifold.
Additional Manufacturer Narrative
Update to d3 and h6.After further investigation, it has been determined that the udi is (b)(4).The investigation involved testing of the actual/suspected device, trend analysis, and analysis of production records.A malfunction was observed without a conclusive finding, as follows: "both syringes were attached to the manifold; both syringes rolled right back off the manifold.The syringes/manifold were unable to stay connected." the cause remains unestablished.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: LHK, US, JERSEY SHORE MEDICAL
• Manufacturer (Section D): PRODUCTOS MEDLINE, S.A. DE C.V; blvd. world trade center no. 1; parque industrial oradel; nuevo laredo, tamaulipas 88285 ; MX 88285
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19081177
• Report Number: 3004122598-2024-00031
• Device Sequence Number: 20401208
• Product Code: OES
• UDI-Device Identifier: 40195327486564
• UDI-Public: 40195327486564
• 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): 02/18/2026

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: VASC1453
• Device Lot Number: 23JBM286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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