MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BLADE,CARBON-STEEL,10,STRL,DISPOSABLE

Catalog Number	CISION10CS
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "blades are rusted in the solution in compartment, never had this issues before with item number, other tools in compartment made from carbon-steel are nto rusting only this item.".
Additional Manufacturer Narrative
The account reported finding rusting blades and stated blades are rusted in the solution in compartment, while other tools in compartment made from carbon-steel are not rusting only this item.A photo and a sample were received for investigation; two boxes of unused items were received, visual inspection identified no issues, and the items appeared brand new and remained in their original packaging with no signs of damage or tampering.Pictures were received, and visual inspection of the images revealed that the customer was subjecting disposable blades designed for single use to a cleaning and sterilization process alongside reusable handles; based on the photos provided by the customer, the complaint of rusting blades is visible therefore confirmed.Finished good production records were reviewed and did not find any nonconformances, the updated cause code was adjusted to dc: traced to user with misuse/mishandling, and the division will continue to monitor the issue for trending.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: BLADE,CARBON-STEEL,10,STRL,DISPOSABLE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kim evangelista ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946769
• Report Number: 1417592-2026-54331
• Device Sequence Number: 10451617
• Product Code: GES
• UDI-Device Identifier: 10193489090109
• UDI-Public: 10193489090109
• 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): 09/30/2026

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: CISION10CS
• Device Lot Number: B01875
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2025
• 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: 07/30/2025
• Initial Report FDA Received Date: 09/30/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown