MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; PAIN TRAY

Catalog Number	DYNJRA1955A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility 3 different occasions where, "there were issues with leaking from either the plunger end or the luer lock at the junction with the needle.The syringes at the time of the issues were replaced for another and no direct patient injuries or issues were reported.The procedures being performed were pain injection cases and were completed".The syringes would leak once the medications were pulled up into them or when the syringe was started to be pushed.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
According to the facility 3 different occasions where, "there were issues with leaking from either the plunger end or the luer lock at the junction with the needle.The syringes at the time of the issues were replaced for another and no direct patient injuries or issues were reported.".

• Common Device Name: PAIN 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: 21778927
• Report Number: 1417592-2025-00163
• Device Sequence Number: 15660878
• Product Code: OFT
• UDI-Device Identifier: 10198459171123
• UDI-Public: 10198459171123
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/04/2025

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: DYNJRA1955A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 04/04/2025
• 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
• Patient Sex: Unknown