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

Catalog Number	ECVC8040B
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rn clamped this port after every use, 4 different times, and when i returned to reuse the line, it was unclamped.
Additional Manufacturer Narrative
It was reported that the rn clamped this port after every use, 4 different times, and when i returned to reuse the line it was unclamped.Since the complaint device and lot number were not available, the investigation was limited; a case of unused kits was received for evaluation, endurance testing of the slide clamp found on each extension tube was performed, and the samples were reviewed periodically over a period of 48 hours with no signs of leaking or clamps becoming disengaged observed.A dimensional evaluation of the clamps included with the returned sample was also performed and all were confirmed to be within specification; the cause code was not confirmed with received sample.Based on the investigation results, a root cause for the reported issue could not be determined.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: DBD-VANTEX 7FR 3L 20CM CVC BUNDLE, CHOIC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: herchelle teodoro ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884656
• Report Number: 1417592-2026-50054
• Device Sequence Number: 10755087
• Product Code: LRO
• UDI-Device Identifier: 00653160367812
• UDI-Public: 00653160367812
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/23/2026

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: ECVC8040B
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/09/2024
• 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: 02/05/2024
• Initial Report FDA Received Date: 09/24/2026
• 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