MAUDE Adverse Event Report: PRODUCTOS MEDLINE MEDLINE; HARDEN WIRE WHEEL

Catalog Number	DYNDA1925A
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that rust was identified on several of the wheels and on the towel inside the wrap.We only have one lot in house, so they are placing them in a large sharps container to access tomorrow.I have requested pictures and the few that we opened outside the core have been quarantined for medline's quality team to review.No adverse event, sterilized product was not usable.There were no reports of death, serious injury, medical intervention, or follow up care.
Event or Problem Description
Rust on device.

• Brand Name: MEDLINE
• Common Device Name: HARDEN WIRE WHEEL
• Manufacturer (Section D): PRODUCTOS MEDLINE; s.a. de c.v. parque industrial; blvd world trade center #106; oradel nuevo laredo, tamaulipas 88285 ; MX 88285
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25021043
• Report Number: 1417592-2026-00363
• Device Sequence Number: 9631864
• Product Code: LRO
• UDI-Device Identifier: 10889942903191
• UDI-Public: 10889942903191
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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: DYNDA1925A
• Device Lot Number: 25HBM747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown