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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the archive sample analysis.Based on the determined risk priority number, the residual risk related to the complaint is considered acceptable.Sol millennium continues to monitor this kind of issue.Additional assessment will be taken if a significant pattern emerges.Unconfirmed.This report was initially submitted on 08/08/2024.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
Customer reported: ahs mdip reference number (id): (b)(4) date of incident (yyyy-mm-dd): (b)(6) 2024 incident details: the substitute is very unsafe! the needle is completely exposed pre and post injection.The cover to go up over needle gets in the way of injecting the syringe and has a high risk for needle sticks.It does require two hands to cover the needle with the attached cover therefore increasing the risk of a needle stick.This is an ongoing issue as the sub is lasting a long time.We use several of these needles every day.
Additional Manufacturer Narrative
This report when initially submitted encountered an internal issue potentially related to database connectivity.This issue was identified while implementing capa-57 which was opened following an fda inspection.

• 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 (Section G): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.; 758 binhai 5th avenue, binhai; industrial park, longwan,; wenzhou city,, zhejiang province 32502 5; CH 325025
• Manufacturer Contact: jarryd franklin ; 311 s. wacker dr.,; suite 4100; chicago, IL 60606
• MDR Report Key: 22035634
• Report Number: 3014312726-2024-00288
• Device Sequence Number: 15650504
• Product Code: FMI
• UDI-Device Identifier: 00818392010480
• UDI-Public: (01)00818392010480
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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 Expiration Date: 02/10/2026
• Device Model Number: SN2558
• Device Lot Number: 02011050
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2021
• 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