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

Catalog Number	ECVC8130
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "fed the guide wire through the access needle, couldn¿t retract the wire from the needle.Had to pull needle and wire, the curved portion of the wire would push past the needle but not pull into the tip of the access needle.".
Additional Manufacturer Narrative
The customer reported that the guidewire was fed through the access needle and couldn¿t be retracted from the needle; the curved portion of the wire would push past the needle but not pull into the tip of the access needle.The investigation was limited without a lot number or a complaint sample to review, production records could not be reviewed, and a review of the nonconforming material reports for the applicable guidewire component reported no issues from the past 24 months.Based on the review of the details provided for the complaint investigation, medline was unable to confirm the complaint issue or that the product failed to meet specifications, and the cause was listed as unconfirmed defect - sample required to determine cause.A review of the ifu determined it instructs, "caution: to avoid possible severing of the guidewire, do not withdraw the guidewire against the needle bevel," and centurion does not recommend retracting the guidewire from the needle.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-3L 7FR 16CM CVC INSERTION BUNDLE
• 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: 50885031
• Report Number: 1417592-2026-50125
• Device Sequence Number: 18589767
• Product Code: OES
• UDI-Device Identifier: 00653160358346
• UDI-Public: 00653160358346
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/23/2026

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: ECVC8130
• 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: 02/21/2024
• 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