MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-VANTEX 7FR 3L 16CM CVC BUNDLE, CHOIC

Catalog Number	ECVC7625B
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "patient lost last purple clamp today.Patient found with no clamp on white lumen.".
Additional Manufacturer Narrative
The patient lost last purple clamp today and was found with no clamp on the white lumen.Since the complaint device was not available, the investigation was limited; unused kits featuring the same slide clamp component were evaluated by endurance testing, and the returned catheters were connected to a full iv bag, primed with water, and each extension tube was clamped, with no signs of leaking or clamps becoming disengaged observed over 48 hours.Dimensional evaluation of the clamps included with the returned sample was performed and all were confirmed to be within specification; based on the review of the details provided, medline was unable to confirm the complaint issue or that the product failed to meet specifications.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 16CM CVC BUNDLE, CHOIC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913947
• Report Number: 1417592-2026-51846
• Device Sequence Number: 14952124
• Product Code: LRO
• UDI-Device Identifier: 00653160368314
• UDI-Public: 00653160368314
• 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): 09/28/2026

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: ECVC7625B
• Was Device Available for Evaluation?: No
• 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: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown