MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; TRAY,SUTURE REMOVAL,MTL IRIS&ADSON FCP

Catalog Number	DYNJ07254A
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint event was reviewed and did not involve a death or serious injury.The reported product problem/issue of rust on component and in packaging information received were reviewed according to complaint handling procedures.The information reviewed does not indicate that a death or serious injury would be likely to occur if the product problem/issue were to recur.There is currently no information indicating that further review by the clinical product surveillance team is required based upon the requirements of the procedures.In the event that further information is received during investigation that indicates the event may potentially be a reportable adverse event, this complaint will be forwarded to the clinical product surveillance team for evaluation.
Event or Problem Description
Rust on component.
Additional Manufacturer Narrative
Added h6 (b) investigation types 3331, 3300, 4121, 4110, and 4111; findings 170 manufacturing problem; but there was no change to the conclusion.

• Brand Name: MEDLINE
• Common Device Name: TRAY,SUTURE REMOVAL,MTL IRIS&ADSON FCP
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24737948
• Report Number: 1417592-2026-00284
• Device Sequence Number: 9242652
• Product Code: LRO
• UDI-Device Identifier: 10080196039654
• UDI-Public: 10080196039654
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 05/21/2026

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 Expiration Date: 09/30/2026
• Device Catalogue Number: DYNJ07254A
• Device Lot Number: 24EBF410
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2024
• 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