MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; VANTEX 7FR 3L 20CM CVC W/US

Catalog Number	ECVC8200
Medical Device Problem Codes	Difficult to Insert (1316); Material Too Soft/Flexible (4007)
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 the guide wire (item# gw3260i) is flimsy and does not allow for catheter insertion ease.
Additional Manufacturer Narrative
The account reported finding guidewire is flimsy, and the complaint stated the guide wire is flimsy and does not allow for catheter insertion ease.A sample was received; the customer returned 2 ea of unopened kits, the samples were not used, the dimensions of the guidewire were confirmed to be within specification, and the guidewire was able to be inserted into the corresponding catheter within the kit.A review of production records did not find any similar nonconformances, incoming inspection records confirmed no nonconformances were observed, and bom reviewed, no observations made that would contribute to the defect reported in the complaint.Based on the complaint details, sample evaluation, and investigation, the complaint cannot be confirmed; the transition from products provided by arrow and those provided by medline may be partially attributable to user preference, and the issue will continue to be monitored.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 20CM CVC W/US
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: diana arizmendi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50914167
• Report Number: 1417592-2026-51852
• Device Sequence Number: 5370179
• Product Code: LRO
• UDI-Device Identifier: 10653160381396
• UDI-Public: 10653160381396
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 09/25/2026

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: ECVC8200
• Device Lot Number: 2025011590
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/21/2025
• 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: 09/28/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown