MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE CONVENIENCE KIT; UNIVERSAL BLOCK TRAY

Catalog Number	DYNJRA1644A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, in the 10ml syringe, the black rubber piece was deteriorated and caused some leaking.There was no further information.
Additional Manufacturer Narrative
According to the facility, in the 10ml syringe, the black rubber piece was deteriorated and caused some leaking.There was no further information.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.Demographics were not given but 0kg was entered since the portal is not accepting the weight field blank.

• Brand Name: MEDLINE CONVENIENCE KIT
• Common Device Name: UNIVERSAL BLOCK TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 24120689
• Report Number: 1417592-2026-00060
• Device Sequence Number: 13185929
• Product Code: OGJ
• UDI-Device Identifier: 10193489440386
• UDI-Public: 10193489440386
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 01/20/2026

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: 03/31/2025
• Device Catalogue Number: DYNJRA1644A
• Device Lot Number: 25CMJ097
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2025
• 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