MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NAMIC NAMIC; MTS,LHK,-,REYNOLDS,RGNST

Catalog Number	60180623
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the stopcock is breaking.It is connected to the winged piece where the grey cord connects, but when used it will actually break off rendering the kit unusable.It doesn't seem like it is loose upon opening the package, but when trying to connect to it, it breaks off.Did not use product, had to open new one.The transducer stop cock broke on the 3 that we had to open.There were no reports of death, serious injury, medical intervention, or follow up care.
Event or Problem Description
Stopcock is breaking.

• Brand Name: NAMIC
• Common Device Name: MTS,LHK,-,REYNOLDS,RGNST
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NAMIC; 10 glens falls technical pk. d; glens falls NY 12801 3864
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25070004
• Report Number: 3015910259-2026-00118
• Device Sequence Number: 18743770
• Product Code: OEZ
• UDI-Device Identifier: 10193489049510
• UDI-Public: 10193489049510
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 60180623
• Device Lot Number: 0000184083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 05/03/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2025
• 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