MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MINI ACCESS 4FR STIFF NT/TG E

Catalog Number	DYNJMAST09
Medical Device Problem Codes	Material Fragmentation (1261); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the complaint involved the tip of guidewire coils shredding after initial insertion, which made the tip of the wire fragile/floppy.
Additional Manufacturer Narrative
The customer reported tip of guidewire coils shredding, and the complaint involved the tip of guidewire coils shredding after initial insertion, which made the tip of the wire fragile/floppy.No sample was received for evaluation; review of the finished good bill of materials/pack build did not reveal any nonconformances, the device history record was reviewed with no nonconformances identified that would have contributed to the reported defect, review of receiving inspection records did not reveal any related nonconformances, and complaint history review found no similar complaints or adverse trend.Based on the investigation results, the reported event was not able to be confirmed at this time and was not able to be replicated because the customer did not use the provided call tag to issue a sample for investigation.Root cause remains inconclusive at this time as the reported defect was not able to be confirmed, and no action is required at this time; medline will continue to monitor for additional occurrences and adverse trends.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: MINI ACCESS 4FR STIFF NT/TG E
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947199
• Report Number: 1417592-2026-54418
• Device Sequence Number: 9624024
• Product Code: OEZ
• UDI-Device Identifier: 40888277586216
• UDI-Public: 40888277586216
• 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): 09/29/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJMAST09
• Device Lot Number: 23HBN014
• 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: 01/31/2024
• Initial Report FDA Received Date: 09/30/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown