MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; VANTEX 7FR 3L 16CM CVC BUNDLE W/US

Catalog Number	ECVC8195A
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that only 2 of the 3 lumens work after the catheter is placed in the patient.They are unable to flush.
Additional Manufacturer Narrative
The customer reported finding unable to flush, and the complaint text states only 2 of the 3 lumens work after the catheter is placed in the patient.A sample was received for investigation; the investigation was limited without return of the reported complaint device, and an unopened kit was evaluated for occlusions and aspiration/flushing, with no occlusions observed and no difficulties withdrawing or expelling water through any of the lumens.Based on the complaint details, sample evaluation, and investigation, the complaint cannot be confirmed.At this time, the root cause cannot be determined, and the incident reported within the complaint is not believed to be due to an occlusion in the device prior to insertion; no medical intervention, serious injury, or follow-up care has been reported.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: VANTEX 7FR 3L 16CM CVC BUNDLE W/US
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50952130
• Report Number: 1417592-2026-55078
• Device Sequence Number: 9534041
• Product Code: LRO
• UDI-Device Identifier: 10653160381143
• UDI-Public: 10653160381143
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• 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): 09/29/2026

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: ECVC8195A
• Device Lot Number: 2024100790
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/18/2025
• 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: 04/15/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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