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

Catalog Number	EMZCCS10500
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "bubbles have been noted to be left in the syringe after following medline's instructions on how to prime syringe.".
Additional Manufacturer Narrative
It was reported that "bubbles have been noted to be left in the syringe after following medline's instructions on how to prime syringe." the customer said that "removing bubbles has not been effective" and that the "bubbles that cannot be expelled from the syringe are larger than pin size." the customer stated that "it takes a lot of work to get the bubbles to expel from the syringe, forcing you to waste 1-3ml of saline at times." the customer reported that "teams have not been using noted syringes with bubbles and have been obtaining prefilled syringes that are stored on par walls." per the customer "reported syringes have not reached the patient." no additional information is available.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.
Additional Manufacturer Narrative
Update to d9: is this device available for evaluation? update to g3: device evaluated by manufacturer.Update to h6: type of investigation (b).Update to h6: investigation findings (c).

• Brand Name: EXCELSIOR CLEARSHIELD
• Common Device Name: SYRINGE, 10ML, SODIUM CHLORIDE
• Manufacturer (Section D): EXCELSIOR MEDICAL, LLC; 1933 heck ave; neptune NJ 07753 4428
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24309463
• Report Number: 2027791-2026-00004
• Device Sequence Number: 18561879
• Product Code: NGT
• UDI-Device Identifier: 00363807011175
• UDI-Public: 00363807011175
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 3146212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2025
• 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