MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; GLMI ARTHROGRAM KIT BIG TREE

Catalog Number	DYNDH1752
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the pa will draw up medication using the 18g needle and 10cc syringes from the kit, and tiny black particles will break apart from one of those two items and end up floating in the syringe.The pa will inspect the syringe for the floating particles and, if present, will discard both the syringe and the needle, then draw up with a brand new one from a separate box.No reports of serious injury or medical intervention.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the pa will draw up medication using the 18g needle and 10cc syringes from the kit, and tiny black particles will break apart from one of those two items and end up floating in the syringe.The pa will inspect the syringe for the floating particles and, if present, will discard both the syringe and the needle, then draw up with a brand new one from a separate box.No reports of serious injury or medical intervention.
Additional Manufacturer Narrative
Update to h6.After further investigation, it has been determined that the investigation involved communication/interviews, trend analysis, an analysis of production records.The device was not returned.The investigation visually confirmed the presence of black particulate, but the cause remains unestablished.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Update to d9, h3, and h6: after further investigation, it has been determined that a sample was returned and evaluated by the manufacturer on 1/16/2026.The investigation involved testing of the actual/suspected device, trend analysis, and analysis of production records.The investigation confirmed the presence of inappropriate material, as evidenced by consistent black particulate matter suspended in the liquid; however, the specific source of the material could not be determined, and the cause remains unestablished.If any additional relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: GLMI ARTHROGRAM KIT BIG TREE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 23998234
• Report Number: 1417592-2026-00011
• Device Sequence Number: 18697754
• Product Code: OJH
• UDI-Device Identifier: 10195327162887
• UDI-Public: 10195327162887
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNDH1752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 01/09/2026; 01/30/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/14/2026; 02/04/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown