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

Catalog Number	ECVC7680
Medical Device Problem Codes	Material Twisted/Bent (2981); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr report summarizes 1 malfunction event that occurred between january 1 and march 31, 2023.The account reported that guidewires contained within egw2008 kits experienced kinking during use.Multiple physicians reported experiencing guidewire kinking while using the kits.No patient information was available.No patient or user injuries were reported.
Additional Manufacturer Narrative
This vmsr submission is part of a retrospective data remediation review.The included events represent 1 malfunction event that medline became aware of during january 1, 2023 through march 31, 2023.1 egw2008 kit was evaluated following reports that the guidewire contained within the kit experienced kinking during use.Evaluation was conducted using a returned unused sample.Visual examination identified that the guidewire had been incorrectly inserted into the j-straightener, resulting in the guidewire being kinked within the straightener.Dimensional inspection confirmed that the guidewire met specification requirements.Because the device could not be used as received, the guidewire was correctly fed into the j-straightener to allow further testing.The guidewire was then inserted through the centurion guiding syringe and 18ga needle included within the complaint kit.No difficulty was encountered during insertion testing and the device performed as intended.Based on the investigation, the reported issue could not be confirmed.Although kinking of the guidewire was observed, the investigation could not confirm that the condition contributed to guidewire kinking during use.The investigation determined that a root cause could not be established based on the available information.Review of production records for the complaint kits and guidewire dispenser assemblies did not identify any nonconformances during first article, in-process, or packaging inspections.The instructions for use advise users not to force the guidewire and to completely withdraw and reattempt insertion if resistance is encountered.1 device was returned for evaluation.The device was not labeled for single use.No devices were identified as reprocessed or reused.No patient or user injuries were 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 20CM CVC BUNDLE US
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945790
• Report Number: 1417592-2026-54140
• Device Sequence Number: 10446230
• Product Code: OES
• UDI-Device Identifier: 00653160348163
• UDI-Public: 00653160348163
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Exemption Number: VMSR
• 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: ECVC7680
• Was Device Available for Evaluation?: Yes
• 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: 03/23/2023
• 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