MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BN CVOR 9FR INTRODUCER/3L KIT

Catalog Number	ECVC7070B
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the dilator will only insert two inches into the catheter.The dilator will not go any further.
Additional Manufacturer Narrative
This is a combination product according to the facility, during preparation for use, the dilator would only insert approximately two inches into the introducer catheter and would not advance further; the affected kits were not used, and alternative devices were utilized.No sample or photo was received for the investigation; the production records could not be reviewed since the lot number was not provided, and review of the bom noted no changes that would result in the complaint issue.Based on the complaint details and investigation, the complaint cannot be confirmed, and the investigation was limited without receipt of the lot number, photo, or sample.Without a lot number or sample for reference, root cause is unidentified and the responsibility is undetermined; 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: BN CVOR 9FR INTRODUCER/3L KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50888889
• Report Number: 1417592-2026-50433
• Device Sequence Number: 18598361
• Product Code: OES
• UDI-Device Identifier: 10653160373308
• UDI-Public: 10653160373308
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 09/24/2026

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: ECVC7070B
• 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: 02/13/2026
• Initial Report FDA Received Date: 09/24/2026
• 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