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

Catalog Number	ECVC7625B
Medical Device Problem Codes	Break (1069); Unraveled Material (1664); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon retrieving guide wire with catheter in place - wire began to unravel than became increasing difficult to fully remove.
Additional Manufacturer Narrative
The customer reported that a critical care np was placing a trialysis hd line, using cvc line wire, and upon retrieving the guide wire with catheter in place, the wire began to unravel and became increasingly difficult to fully remove; manual pressure was applied immediately for hemostasis and a trauma md removed the guidewire.The returned complaint sample was forwarded for cleaning and disinfection at medline¿s renewal facility, returned, and evaluated by members of centurion's qa and engineering departments.The evaluation confirmed the core wire had broken which led to the unraveling of the wire, and a bend in the core wire was also observed.Considering the vendor's investigation results have not been received at this time, a root cause cannot be positively identified, and the cause was documented as cannot determine cause with received sample.There were no reports of death, serious injury, medical intervention, or follow up care.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: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50945463
• Report Number: 1417592-2026-54083
• Device Sequence Number: 10348666
• Product Code: LRO
• UDI-Device Identifier: 00653160368314
• UDI-Public: 00653160368314
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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?: Yes
• Date Returned to Manufacturer: 03/12/2024
• 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: 03/04/2024
• Initial Report FDA Received Date: 09/30/2026
• 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