MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; ORTHO

Catalog Number	DYNJ910496B
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suction tubing has debris inside.
Additional Manufacturer Narrative
The account reported finding suction tubing stained and the customer reported the suction tubing has debris inside.A photo and a sample were received; in the photo, it appeared as if there were black particles or some type of black residue within the tubing, and the sample review found the same unknown particles or residues were staining within the ridges of the exterior surface of the tubing, not within the tubing as originally observed with the photo.The reported issue of staining was confirmed because dark stains were observed on the suction tubing of the pack, but with the information provided it could not be determined at what point this occurred.Components may be received stained from the supplier or can become stained during transit or storage, and the division 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: ORTHO
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata peruri ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50867961
• Report Number: 1417592-2026-48654
• Device Sequence Number: 15797636
• Product Code: OJH
• UDI-Device Identifier: 10198459330759
• UDI-Public: 10198459330759
• 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): 09/22/2026

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: DYNJ910496B
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2025
• 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: 07/16/2025
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (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