MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY,SUTURE REMOVAL,MTL LITT

Catalog Number	MDS708555
Medical Device Problem Codes	Corroded (1131); Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they have had about 20 now that have had an issue as far as them looking "rusty" in some areas or even having some kind of red fuzz on it.
Additional Manufacturer Narrative
The account reported finding rust on instruments, with about 20 looking "rusty" in some areas or having some kind of red fuzz on it.A photo and a sample were received for investigation; three photos and three opened kits were reviewed, and small spots were observed on the scissors, with no rust seen on the other blade, between the hinges, on the forceps component, or other area of the kit.Small spots of what appeared to be rust were observed on scissors item 105916 scs litt fg 4.5, confirming the reported issue.The vendor reviewed the returned samples and determined that the root cause is result of a burn mark that was made due to the steel meeting the polishing brush, resulting in "yellow tarnish" and not rust; no additional action was taken by the vendor at this time, and the supplier quality team will monitor this issue for trending purposes.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: TRAY,SUTURE REMOVAL,MTL LITT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azra halilovic ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50803218
• Report Number: 1417592-2026-43440
• Device Sequence Number: 12922565
• Product Code: MCZ
• UDI-Device Identifier: 10080196999040
• UDI-Public: 10080196999040
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/15/2026

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: MDS708555
• Device Lot Number: 24IBF346
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2025
• 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: 03/05/2025
• Initial Report FDA Received Date: 09/17/2026
• 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