MAUDE Adverse Event Report: EXCELSIOR MEDICAL, LLC MEDLINE; SYRINGE, 10ML, SODIUM CHLORIDE

Catalog Number	EMZCCS10500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that when connecting the sterile flush from the access kit to the injection cap, the tip of the syringe broke off in the injection cap.There were no reports of death, serious injury, medical intervention, or follow up care.
Event or Problem Description
When connecting the sterile flush from the access kit to the injection cap, the tip of the syringe broke off in the injection cap.

• Brand Name: MEDLINE
• Common Device Name: SYRINGE, 10ML, SODIUM CHLORIDE
• Manufacturer (Section D): EXCELSIOR MEDICAL, LLC; 1933 heck avenue; neptune NJ 07753 4428
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25184531
• Report Number: 2027791-2026-00010
• Device Sequence Number: 10543446
• Product Code: NGT
• UDI-Device Identifier: 00363807011175
• UDI-Public: 00363807011175
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K191378
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2026

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: EMZCCS10500
• Device Lot Number: 3145802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2025
• 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