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

Catalog Number	ECVC7070B
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there were four incidents with four different kits where the dilator will only insert two inches into the catheter.The dilator will not go any further.".
Additional Manufacturer Narrative
According to the facility, during preparation for use, the 9 fr introducer was being prepped when an attempt was made to insert the blue obturator/dilator, and the blue obturator/dilator would only advance approximately two inches into the introducer after several attempts.A sample was received for investigation; 5 complaint samples were received, it was observed that the dilator was unable to advance through the catheter, 4 samples were measured via the keyence measurement system, finished good production records were reviewed, and finished good pack build was reviewed.Based on the complaint details, sample evaluation, and investigation, the complaint is confirmed; the catheter was found to have an undersized inner diameter in all 4 tested samples, and 2 of 4 dilator samples tested were found to be oversized.The reported condition is confirmed to be component manufacturing-related based on the nature of the defects observed; however, the samples received were insufficient to determine a specific root cause, and evaluation of the returned samples confirmed that the returned components did not meet the applicable specifications.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: maya mcknight ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50869942
• Report Number: 1417592-2026-48977
• Device Sequence Number: 9224077
• Product Code: OES
• UDI-Device Identifier: 10653160373308
• UDI-Public: 10653160373308
• Combination Product (Y/N): N
• 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): 09/22/2026

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: ECVC7070B
• Device Lot Number: 2025092290
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/19/2026
• 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: 09/23/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown