MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC SOL-MILLENNIUM; SOL-CARE SAFETY NEEDLE 25G*5/8"

Model Number	SN2558
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
"customer reported ems acp received a needle stick injury post im injection as the im needle did not safety lock after being pushed up.
Additional Manufacturer Narrative
This report was initially submitted on 12/12/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Additional Manufacturer Narrative
This report when initially submitted encountered an internal issue potentially related to database connectivity.This issue was identified while implementing (b)(4) which was opened following an fda inspection.No samples/pictures or other evidence of impacted devices was received from the customer for evaluation of the reported issue.The batch number information is unknown.The residual risk associated with the complaint is deemed acceptable based on the calculated risk priority number.Sol millennium will continue to monitor this kind of issue and should a strong trend arise, further evaluation will be taken.This supplemental mdr is being submitted to the report type - product problem and adverse event provided in the initial mdr [3014312726-2024-00372].The previously reported was incorrect.The correct report type is product problem only.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: SOL-CARE SAFETY NEEDLE 25G*5/8"
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC; 311 s. wacker dr; suite 4100; chicago IL 60606
• Manufacturer Contact: jarryd franklin ; 311 s. wacker dr; suite 4100; chicago
• MDR Report Key: 22035563
• Report Number: 3014312726-2024-00372
• Device Sequence Number: 15648114
• Product Code: FMI
• UDI-Device Identifier: 20818392010484
• UDI-Public: (01)20818392010484
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123684
• 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 Health Care Professional
• Type of Report: Initial,Followup
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SN2558
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown