MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; SYRINGE, PISTON

Model Number	SSN100235
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Rn was using new safety needle (23g) while administering covid vaccine.The safety needle did not close all the way and the rn was stuck when trying to place needle in the sharps container.

• Brand Name: MEDLINE
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 23778532
• Report Number: 23778532
• Device Sequence Number: 10083946
• Product Code: FMF
• UDI-Device Identifier: 10193489031959
• UDI-Public: (01)10193489031959
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/24/2025
• Report Date (Section F): 10/24/2025

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 Model Number: SSN100235
• Device Catalogue Number: SSN100235
• Device Lot Number: (10)89724110001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2025
• 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: Disability; Other; Life Threatening
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/24/2025