MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-SINGLE SHOT NERVE BLOCK TRAY

Catalog Number	DYNJRA2077
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The account reported that several of the 3-way stopcocks in their custom nerve kits have been malfunctioning or are broken and could not confirm quantity.A sample was received; the sample consisted of one stopcock, which was attached to a 20ml syringe filled with tap water to test the stopcock for leaks, and finished good production records and pack build history were reviewed.The stopcock failed the leak test due to a visible leak when the plunger was depressed on the syringe, and a crack in the white valve that directs the fluid path was found.Based on the complaint details, the root cause is considered to be a vendor product issue relating to the component manufacturing process; there were no issues with the pack build that would contribute to the reported issue.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
Event or Problem Description
It was reported that "several of the 3-way stopcocks in our custom nerve kits have been malfunctioning or are broken.".

• Brand Name: MEDLINE
• Common Device Name: DBD-SINGLE SHOT NERVE BLOCK TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50947530
• Report Number: 1417592-2026-54457
• Device Sequence Number: 9499658
• Product Code: OGJ
• UDI-Device Identifier: 40195327278916
• UDI-Public: 40195327278916
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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 Catalogue Number: DYNJRA2077
• Device Lot Number: 23ABN415
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/06/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown