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

Catalog Number	DYNJRA1991A
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "10cc syringes provided in the block trays leak with the provided 27-gauge hypodermic needle in the tray." the customer reported that "tightening the needle-syringe connection" partially resolves the leakage issue but creates difficulty removing the needle so that it can be replaced with a spinal needle to access "deeper tissue." the customer stated that the procedure was "completed successfully" and that there was "no patient injury." 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 "10cc syringes provided in the block trays leak with the provided 27-gauge hypodermic needle in the tray." the customer reported that "tightening the needle-syringe connection" partially resolves the leakage issue but creates difficulty removing the needle so that it can be replaced with a spinal needle to access "deeper tissue.".

• Common Device Name: BLOCK TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23033729
• Report Number: 1417592-2025-00468
• Device Sequence Number: 9514945
• Product Code: OFT
• UDI-Device Identifier: 10195327306045
• UDI-Public: 10195327306045
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/11/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJRA1991A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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