MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - EXCELSIOR; SYRINGE, 10ML SALINE IN 10ML

Catalog Number	EMZE010001
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility on (b)(6) 2025 "registered nurse attempted to flush an iv and the plunger cracked, no force was used, patient was unharmed, and the rn used another flush to finish the job".No additional information was provided.The sample was requested for evaluation.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 on (b)(6) 2025 "registered nurse attempted to flush an iv and the plunger cracked, no force was used, patient was unharmed, and the rn used another flush to finish the job".

• Common Device Name: SYRINGE, 10ML SALINE IN 10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - EXCELSIOR; 1933 heck avenue; neptune NJ 07753 4428
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23358705
• Report Number: 2027791-2025-00018
• Device Sequence Number: 15678536
• Product Code: NGT
• UDI-Device Identifier: 00363807100015
• UDI-Public: 00363807100015
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 10/22/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: EMZE010001
• Device Lot Number: 3145749
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2025
• 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