MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - EXCELSIOR 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)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, bubbles were noted to remain in the syringe after following medline's instructions for priming syringes.The facility reported that removing all bubbles was not effective and that the bubbles unable to be expelled were larger than pin size.The facility further reported that significant effort was required to expel the bubbles, resulting in the wasting of approximately 1-3 ml of saline at times.The facility stated that the syringes with bubbles were not used and that staff obtained alternative prefilled syringes from par walls.The reported syringes did not reach the patient.
Additional Manufacturer Narrative
According to the facility, bubbles were noted to remain in the syringe after following medline's instructions for priming syringes.The facility reported that removing all bubbles was not effective and that the bubbles unable to be expelled were larger than pin size.The facility further reported that significant effort was required to expel the bubbles, resulting in the wasting of approximately 1-3 ml of saline at times.The facility stated that the syringes with bubbles were not used and that staff obtained alternative prefilled syringes from par walls.The reported syringes did not reach the patient.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, h3, and h6.After further investigation, it was determined that the device was returned to and evaluated by the manufacturer on 3/25/2026.The investigation included testing of the actual/suspected device, analysis of production records, and trend analysis.A malfunction was observed without a conclusive finding.If any additional relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: EXCELSIOR CLEARSHIELD
• Common Device Name: SYRINGE, 10ML, SODIUM CHLORIDE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - EXCELSIOR; 1933 heck ave; neptune NJ 07753
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24292343
• Report Number: 2027791-2026-00003
• Device Sequence Number: 18474834
• 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): 04/05/2026

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: 3145578
• 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: 02/09/2026
• Supplement Report FDA Received Date: 04/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown