MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA. SOL-MILLENNIUM; NEEDLE, SAFETY 25GX5/8" (HINGED STYLE)

Model Number	16-N2558S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no evidence of quality issues associated with this complaint based on the return sample and 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 03/25/2025.Due to issues with displaying the initial submission, this submission contains both initial and supplemental information.
Event or Problem Description
"customer reported returning the needle due to malfunction in the safety feature, which does not close properly.On march 24,2025, the customer responded to the probing questions and confirmed that this issue was observed with a few needles, resulting in an employee injury.They further explained that when closing of the safety device, the needle tends to bend and pierce through the orange safety cover.
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.This supplemental mdr is being submitted to correct "report type, manufacturing site information (g1)" provided in the initial mdr 3014312726-2025-00070.The previously reported report type is adverse event and product problem was incorrect and manufacturing site information (g1) was also incorrect.The correct report type is product problem only and correct manufacturing site information (g1) is zhejiang kindly medical devices co., ltd.
Event or Problem Description
Customer reported returning the needle due to malfunction in the safety feature, which does not close properly.On (b)(6) 2025, the customer responded to the probing questions and confirmed that this issue was observed with a few needles, resulting in an employee injury.They further explained that when closing of the safety device, the needle tends to bend and pierce through the orange safety cover.Update: the customer confirmed that when closing of the safety device, the needle tends to bend and pierce through the orange safety cover.There was one incident where this resulted in a needlestick to an employee.No treatment was required.

• Brand Name: SOL-MILLENNIUM
• Common Device Name: NEEDLE, SAFETY 25GX5/8" (HINGED STYLE)
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA.; 311 s wacker dr, suite 4100; chicago IL 60606
• Manufacturer Contact: jarryd franklin ; no. 758, 5th binhai road; binhai industrial park; longwan, 325025 wenzhou, zhejiang, IL 32502-5 ; CH 325025
• MDR Report Key: 22035481
• Report Number: 3014312726-2025-00070
• Device Sequence Number: 8655777
• Product Code: FMI
• UDI-Device Identifier: 10612479244655
• UDI-Public: (01)10612479244655(10)CSOD05-01
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,Health Professional,Distributor
• 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: 16-N2558S
• Device Lot Number: CSOD05-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• 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): Yes
• Date Device Manufactured: 07/15/2021
• 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