MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CVC TRIPLE LUMEN 7FR PI 20CM

Catalog Number	ECVC8350
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when the wire is passed through, it gets stuck just before exiting the brown port.Sometimes there is a link at the tubing just before the brown port that cannot otherwise be straightened out".
Additional Manufacturer Narrative
The account reported finding guidewire getting stuck, and the customer reported that the wire gets stuck just before exiting the brown port.No sample or photo was received for the investigation; finished good production records and the finished good pack build were reviewed, and 9ea samples were obtained from inventory for the catheter component.An ngw2008 guidewire was able to pass through all 9 samples without issue, but the samples were then bisected along the distal hub and all 9 samples were found to contain voids; because no customer sample was received, the complaint lot could not be evaluated.Given the size and location of the voids, it is possible that during manipulation of the device, the guidewire could catch inside the pocket created by the void and fail to advance further; the complaint was provided to the component manufacturing facility for further evaluation and the division will monitor this issue for trending purposes.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: CVC TRIPLE LUMEN 7FR PI 20CM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50856805
• Report Number: 1417592-2026-47956
• Device Sequence Number: 9953563
• Product Code: LRO
• UDI-Device Identifier: 10653160370062
• UDI-Public: 10653160370062
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/22/2026

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: ECVC8350
• Device Lot Number: 2025050990
• 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: 11/24/2025
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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