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

Catalog Number	EMZE010001
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, on 7/9/2025, "hole in plunger noticed while injecting" with syringe."partial amount of product was injected into port." per the facility, "rn obtained a second syringe to complete the flush procedure" and patient is being monitored for infection.
Additional Manufacturer Narrative
According to the facility, on 7/9/2025, "hole in plunger noticed while injecting" with syringe."partial amount of product was injected into port." per the facility, "rn obtained a second syringe to complete the flush procedure" and patient is being monitored for infection.The product has been 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.

• Common Device Name: SYRINGE, 10ML SALINE IN 10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP- EXCELSIOR; 1933 heck avenue; neptune NJ 07753 4428
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 22777659
• Report Number: 2027791-2025-00014
• Device Sequence Number: 15733383
• Product Code: NGT
• UDI-Device Identifier: 00363807100015
• UDI-Public: 00363807100015
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 08/11/2025

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: 3145319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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 Age: 78 YR
• Patient Sex: Male