MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; UNIVERSAL BLOCK TRAY-LF

Catalog Number	DYNJRA0496A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer, the 10 cc syringe feels clogged, meaning you cannot push it down without causing leaking from the plunger.
Additional Manufacturer Narrative
According to the customer, the 10 cc syringe feels clogged, meaning you cannot push it down without causing leaking from the plunger.No additional information at this time.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.
Additional Manufacturer Narrative
Updated d4: lot number.Updated d4: expiration date.Updated h4: manufacturing date.Updated d9: device available for evaluation and date returned to manufacturer.Updated h3: device evaluated by manufacturer.Updated h6: type of investigation (b).Updated h6: investigation findings (c).

• Brand Name: MEDLINE
• Common Device Name: UNIVERSAL BLOCK TRAY-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093-2753 ; 2173279112
• MDR Report Key: 24484133
• Report Number: 1417592-2026-00165
• Device Sequence Number: 14703214
• Product Code: OGJ
• UDI-Device Identifier: 10198459137259
• UDI-Public: 10198459137259
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJRA0496A
• Device Lot Number: 25JBX907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2025
• 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